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ammonium hydroxide and Fever

ammonium hydroxide has been researched along with Fever in 20 studies

azane : Saturated acyclic nitrogen hydrides having the general formula NnHn+2.

Fever: An abnormal elevation of body temperature, usually as a result of a pathologic process.

Research Excerpts

ExcerptRelevanceReference
" Fever is a complex interplay of immune, metabolic, and stress responses, yet its benefit in autistic disorders (ASD) may derive largely from a single response - release of the amino acid glutamine from skeletal muscles as provisional fuel."7.79Does infectious fever relieve autistic behavior by releasing glutamine from skeletal muscles as provisional fuel? ( Good, P, 2013)
" Fever is a complex interplay of immune, metabolic, and stress responses, yet its benefit in autistic disorders (ASD) may derive largely from a single response - release of the amino acid glutamine from skeletal muscles as provisional fuel."3.79Does infectious fever relieve autistic behavior by releasing glutamine from skeletal muscles as provisional fuel? ( Good, P, 2013)
" Safety endpoints included adverse events, hyperammonemic crises (HACs), and growth and development."1.46Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years. ( Berry, SA; Diaz, GA; Ficicioglu, C; Harding, CO; Lichter-Konecki, U; Longo, N; McCandless, SE; Robinson, B; Smith, WE; Vockley, J; Zori, R, 2017)
" The results show that a binge dosing regimen of METH to the rat increased plasma and brain ammonia concentrations that were paralleled by evidence of hepatotoxicity."1.38Peripheral ammonia as a mediator of methamphetamine neurotoxicity. ( Halpin, LE; Yamamoto, BK, 2012)
"Fever, psychomotor agitation, and arterial hypertension were more frequently observed preceding episodes of severe intracranial hypertension, and more than 50% of FHF patients with uncontrolled intracranial hypertension sustained severe brain injury in our series."1.29Factors associated with severe intracranial hypertension in candidates for emergency liver transplantation. ( Bell, R; Martin, P; Moritz, MJ; Muñoz, SJ; Northrup, B; Radomski, J, 1993)
"Thirty patients who had gastric varices with gastrorenal or gastrocaval collaterals underwent balloon-occluded retrograde transvenous obliteration."1.29Balloon-occluded retrograde transvenous obliteration for gastric varices with gastrorenal or gastrocaval collaterals. ( Koito, K; Morita, K; Nagakawa, T; Namieno, T, 1996)
" Although there were not overall group differences in the dose-response data, there was a significant increase in the hypothermia induced by 8-hydroxy(di-n-propylamino)tetralin in sparse fur compared with control mice (p less than 0."1.28Brain serotonin2 and serotonin1A receptors are altered in the congenitally hyperammonemic sparse fur mouse. ( Anegawa, NJ; Batshaw, ML; Coyle, JT; Gorry, E; Lucki, I; Qureshi, IA; Robinson, MB, 1992)
"Seizure is a common problem evaluated in pediatric emergency departments."1.28Emergency department laboratory evaluation of children with seizures: dogma or dilemma? ( Davis, AT; Nypaver, MM; Reynolds, SL; Tanz, RR, 1992)

Research

Studies (20)

TimeframeStudies, this research(%)All Research%
pre-19909 (45.00)18.7374
1990's5 (25.00)18.2507
2000's1 (5.00)29.6817
2010's5 (25.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Berry, SA1
Longo, N1
Diaz, GA1
McCandless, SE1
Smith, WE1
Harding, CO1
Zori, R1
Ficicioglu, C1
Lichter-Konecki, U1
Robinson, B1
Vockley, J1
Northrop, NA1
Halpin, LE2
Yamamoto, BK2
Orton, DJ1
Gifford, JL1
Seiden-Long, I1
Khan, A1
de Koning, L1
Good, P1
CONSTANTSAS, NS1
DANELATOU-ATHANASSIADOU, C1
Burgery, FJ1
Fuhrman, FA1
Linnane, DM1
Bracken, RM1
Brooks, S1
Cox, VM1
Ball, D1
Muñoz, SJ1
Moritz, MJ1
Bell, R1
Northrup, B1
Martin, P1
Radomski, J1
Koito, K1
Namieno, T1
Nagakawa, T1
Morita, K1
Hinnie, J1
Colombo, JP1
Wermuth, B1
Dryburgh, FJ1
Goldberg, RN1
Cabal, LA1
Sinatra, FR1
Plajstek, CE1
Hodgman, JE1
Kruckenberg, SM1
Cook, JE1
Feldman, BF1
Robinson, MB1
Anegawa, NJ1
Gorry, E1
Qureshi, IA1
Coyle, JT1
Lucki, I1
Batshaw, ML1
Nypaver, MM1
Reynolds, SL1
Tanz, RR1
Davis, AT1
Jacob, S1
Holm, E1
Fischer, B1
Burger, FJ2
Du Plessis, JP1
Bieler, EU1
Lategan, PJ1
Hossaini, AA1
Boyan, CP1
Engelbrecht, FM1
Jordaan, EM1
Bester, P1
Huttenlocher, PR1
Schwartz, AD1
Klatskin, G1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)[NCT02246218]Phase 427 participants (Actual)Interventional2014-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 0 Months to <2 Months Participants

"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants < 2 months of age, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4

Interventionpercentage of participants (Number)
RAVICTI: Age 0 to < 2 Months100

Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 2 Months to <2 Years Participants

"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants 2 months of age and older, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4

Interventionpercentage of participants (Number)
RAVICTI: Age 2 Months to < 2 Years100

Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 0 to < 2 Months1321.18

Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years246.126

Plasma PAA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months115.3

Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months98.98

Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years4.197

Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 0 to < 2 Months9.85

Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 2 Months to < 2 Years7.422

Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 0 to < 2 Months1384.12

Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years583.835

Plasma PAGN Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months102.1

Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months69.39

Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years20.62

Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 0 to < 2 Months11.72

Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 2 Months to < 2 Years6.573

Plasma PBA Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years280.936

Plasma PBA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg*hr/mL (Mean)
RAVICTI: Age 0 to < 2 Months374.53

Plasma PBA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months46.2

Plasma PBA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 0 to < 2 Months4.8

Plasma PBA Minimum Plasma Concentration (Cmin) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years1.697

Plasma PBA Time to Cmax (Tmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 2 Months to < 2 Years8.383

Plasma PBA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionhours (Mean)
RAVICTI: Age 0 to < 2 Months9.39

Plasma Phenylacetate/Phenylacetic Acid (PAA) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years36.52

Plasma Phenylacetylglutamine (PAGN) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years62.45

Plasma Phenylbutyrate/Phenylbutyric Acid (PBA) Maximum Plasma Concentration (Cmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
RAVICTI: Age 2 Months to < 2 Years42.44

Rate of HACs: Cohort of 0 Months to <2 Months Participants

HAC is defined as having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension was calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6

InterventionHACs per half-year of patient exposure (Number)
RAVICTI: Age 0 to < 2 Months0.003

Rate of Hyperammonemic Crises (HACs): Cohort of 2 Months to <2 Years Participants

HAC is defined having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension is calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6

InterventionHACs per half-year of patient exposure (Number)
RAVICTI: Age 2 Months to < 2 Years0.005

Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months84.9726.8125.1650.0518.7757.4343.6533.418.7525.752.5016.10

Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years122.43-54.507.80-16.33-13.000.25-2.2030.8022.2039.0048.00

Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months508.8321.04-27.62-15.09-113.98-99.82-138.16-56.08-181.50-103.75-184.00-219.93

Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years750.43-184.33-174.60-374.00-252.75-370.25-113.20-446.53-450.50-149.00195.00

Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months142.68-49.09-1.62-20.46-67.32-75.45-35.94-73.09-178.50-139.501.00-55.31

Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years54.862.674.20-25.67-20.25-20.00-16.40-6.73-13.33-18.001.50

Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months133.67-81.91-60.80-51.66-82.82-118.55-11.85-115.09-249.50-195.756.00-82.54

Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years90.86-0.839.80-33.00-31.25-39.50-25.40-19.13-34.37-40.00-1.50

Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months593.8047.85-2.4634.96-95.21-42.39-94.51-22.66-172.75-78.00-181.50-203.83

Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years872.86-238.83-166.80-390.33-265.75-370.00-115.40-415.73-428.30-110.00243.00

Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionμmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months181.49-63.96-39.04-23.86-74.41-98.672.64-90.40-238.25-137.0038.00-72.78

Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Interventionµmol/L (Mean)
BaselineDay 7 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years171.434.0040.60-27.33-31.50-56.00-21.60-11.90-48.87-46.005.00

Assessment of Growth and Development: Baseline and Change From Baseline in BMI Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionz-score (Mean)
BaselineMonth 1 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months-0.0544-0.2158-0.2598-0.1617-0.02640.08280.01360.46140.66460.68300.33080.7743

Assessment of Growth and Development: Baseline and Change From Baseline in Body Mass Index (BMI) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionz-score (Mean)
BaselineMonth 1 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years0.8107-0.2385-0.02490.18150.44340.14840.24970.64070.4164-0.2997-0.20380.5581

Assessment of Growth and Development: Baseline and Change From Baseline in Body Surface Area (BSA) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionz-score (Mean)
BaselineMonth 1 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 2 Months to < 2 Years0.7143-0.2105-0.07040.10650.33650.10430.18420.48750.2944-0.3661-0.22140.4310

Assessment of Growth and Development: Baseline and Change From Baseline in BSA Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

Interventionz-score (Mean)
BaselineMonth 1 change from BaselineMonth 2 change from BaselineMonth 3 change from BaselineMonth 4 change from BaselineMonth 5 change from BaselineMonth 6 change from BaselineMonth 9 change from BaselineMonth 12 change from BaselineMonth 15 change from BaselineMonth 18 change from BaselineMonth 24 change from Baseline
RAVICTI: Age 0 to < 2 Months-0.19800.23360.20060.26840.23720.18100.29020.16790.13080.15950.10500.7341

Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
Hour 00.5 to 1.5 hours1.5 to 2.5 hours4 to 6 hours7.5 to 8.5 hours12 to 24 hours
RAVICTI: Age 0 to < 2 Months11.146.262.534.622.835.2

Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
Hour 00.5 to 1.5 hours1.5 to 2.5 hours4 to 6 hours7.5 to 8.5 hours12 to 24 hours
RAVICTI: Age 2 Months to < 2 Years18.786.507.292.604.484.31

Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, End of Trial (up to Month 15)

Interventionμg/mL (Mean)
Day 7Month 1Month 2Month 3Month 4Month 5Month 6Month 9Month 12Month 15End of trial
RAVICTI: Age 0 to < 2 Months23.714.612.314.46.413.25.511.86.04.911.6

Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, Month 18, End of Trial (up to Month 18)

Interventionμg/mL (Mean)
Day 7Month 1Month 2Month 3Month 4Month 5Month 6Month 9Month 15Month 18End of trial
RAVICTI: Age 2 Months to < 2 Years5.824.443.694.657.143.271.594.102.041.647.0

Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
Hour 00.5 to 1.5 hours1.5 to 2.5 hours4 to 6 hours7.5 to 8.5 hours12 to 24 hours
RAVICTI: Age 0 to < 2 Months3530.431828174622603530.434404

Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC

Interventionμg/mL (Mean)
Hour 00.5 to 1.5 hours1.5 to 2.5 hours4 to 6 hours7.5 to 8.5 hours12 to 24 hours
RAVICTI: Age 2 Months to < 2 Years327341403145520239507561

Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants

(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, End of Trial (up to Month 15)

Interventionμg/mL (Mean)
Day 7Month 1Month 2Month 3Month 4Month 5Month 6Month 9Month 12Month 15End of trial
RAVICTI: Age 0 to < 2 Months46434517411670372826697358837006584739156939

Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants

(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, End of Trial (up to Month 18)

Interventionμg/mL (Mean)
Day 7Month 1Month 2Month 3Month 4Month 5Month 6Month 9Month 12Month 15Month 18End of trial
RAVICTI: Age 2 Months to < 2 Years885962747386114562141661295347935725806400525025333

Number of Participants With TEAEs, Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 0 Months to <2 Months Participants

An AE is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 10.67 [6.142] months).

InterventionParticipants (Count of Participants)
≥ 1 TEAE≥ 1 Related TEAE≥ 1 Serious TEAE≥ 1 Serious Related TEAEFatal Outcome TEAE≥ 1 TEAE Leading to Study Discontinuation
RAVICTI: Age 0 to < 2 Months161011001

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 2 Months to <2 Years Participants

An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months).

InterventionParticipants (Count of Participants)
≥ 1 TEAE≥ 1 Related TEAE≥ 1 Serious TEAE≥ 1 Serious Related TEAEFatal Outcome TEAE≥ 1 TEAE Leading to Study Discontinuation
RAVICTI: Age 2 Months to < 2 Years1046011

Trials

1 trial available for ammonium hydroxide and Fever

ArticleYear
Effects of hyperthermia on the metabolic responses to repeated high-intensity exercise.
    European journal of applied physiology, 2004, Volume: 93, Issue:1-2

    Topics: Adult; Ammonia; Body Temperature; Energy Metabolism; Energy Transfer; Fever; Humans; Lactic Acid; Ma

2004

Other Studies

19 other studies available for ammonium hydroxide and Fever

ArticleYear
Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years.
    Molecular genetics and metabolism, 2017, Volume: 122, Issue:3

    Topics: Ammonia; Child, Preschool; Cough; Disease Management; Drug-Related Side Effects and Adverse Reaction

2017
Peripheral ammonia and blood brain barrier structure and function after methamphetamine.
    Neuropharmacology, 2016, Volume: 107

    Topics: Ammonia; Animals; Blood-Brain Barrier; Capillaries; Capillary Permeability; Central Nervous System S

2016
Critically High Plasma Ammonia in an Adolescent Girl.
    Clinical chemistry, 2016, Volume: 62, Issue:12

    Topics: Ammonia; Arginine; Child; Clinical Chemistry Tests; Diagnostic Errors; Fatigue; Female; Fever; Heada

2016
Peripheral ammonia as a mediator of methamphetamine neurotoxicity.
    The Journal of neuroscience : the official journal of the Society for Neuroscience, 2012, Sep-19, Volume: 32, Issue:38

    Topics: Alanine Transaminase; Ammonia; Analysis of Variance; Animals; Aspartate Aminotransferases; Benzodiaz

2012
Does infectious fever relieve autistic behavior by releasing glutamine from skeletal muscles as provisional fuel?
    Medical hypotheses, 2013, Volume: 80, Issue:1

    Topics: Ammonia; Autistic Disorder; Brain; Energy Metabolism; Fasting; Fever; Glutamine; Humans; Muscle, Ske

2013
EXCRETION OF AMINO ACIDS IN CHILDHOOD. A RELIABLE METHOD FOR THE DETERMINATION OF AMINO ACID NITROGEN IN URINE.
    Clinica chimica acta; international journal of clinical chemistry, 1964, Volume: 9

    Topics: Adolescent; Amino Acid Metabolism, Inborn Errors; Amino Acids; Ammonia; Body Fluids; Child; Collagen

1964
EVIDENCE OF INJURY TO TISSUES AFTER HYPERTHERMIA.
    The American journal of physiology, 1964, Volume: 206

    Topics: Ammonia; Animals; Cerebral Cortex; Fever; Hot Temperature; Lagomorpha; Liver; Metabolism; Pentobarbi

1964
Factors associated with severe intracranial hypertension in candidates for emergency liver transplantation.
    Transplantation, 1993, Volume: 55, Issue:5

    Topics: Adult; Alanine Transaminase; alpha-Fetoproteins; Ammonia; Bilirubin; Brain Injuries; Contraindicatio

1993
Balloon-occluded retrograde transvenous obliteration for gastric varices with gastrorenal or gastrocaval collaterals.
    AJR. American journal of roentgenology, 1996, Volume: 167, Issue:5

    Topics: Ammonia; Bilirubin; Blood Urea Nitrogen; Catheterization; Collateral Circulation; Contrast Media; Cr

1996
N-Acetylglutamate synthetase deficiency responding to carbamylglutamate.
    Journal of inherited metabolic disease, 1997, Volume: 20, Issue:6

    Topics: Acetyltransferases; Amino-Acid N-Acetyltransferase; Ammonia; Brain Diseases; Consanguinity; Fever; G

1997
Hyperammonemia associated with perinatal asphyxia.
    Pediatrics, 1979, Volume: 64, Issue:3

    Topics: Ammonia; Asphyxia Neonatorum; Female; Fever; Follow-Up Studies; Heart Rate; Hepatic Encephalopathy;

1979
Clinical toxicities of pet and caged rodents and rabbits.
    The Veterinary clinics of North America, 1975, Volume: 5, Issue:4

    Topics: Abortion, Veterinary; Ammonia; Anesthetics; Animals; Anti-Bacterial Agents; Bezoars; Chinchilla; Con

1975
Brain serotonin2 and serotonin1A receptors are altered in the congenitally hyperammonemic sparse fur mouse.
    Journal of neurochemistry, 1992, Volume: 58, Issue:3

    Topics: 8-Hydroxy-2-(di-n-propylamino)tetralin; Ammonia; Animals; Behavior, Animal; Binding Sites; Brain; Do

1992
Emergency department laboratory evaluation of children with seizures: dogma or dilemma?
    Pediatric emergency care, 1992, Volume: 8, Issue:1

    Topics: Adolescent; Adult; Age Factors; Ammonia; Blood Glucose; Calcium; Child; Child, Preschool; Electrolyt

1992
Effects of hyperthermia on the peripheral metabolism of ammonia and glutamine.
    Metabolism: clinical and experimental, 1989, Volume: 38, Issue:8 Suppl 1

    Topics: Acid-Base Equilibrium; Alanine; Ammonia; Arteries; Blood Glucose; Body Temperature; Fatty Acids, Non

1989
Further studies on the chemical changes in the blood and tissues of rats during hyperthermia.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1972, Nov-18, Volume: 46, Issue:46

    Topics: Amino Acids; Ammonia; Animals; Body Temperature; Capillary Permeability; Endothelium; Fever; Hot Tem

1972
Transfusion reactions.
    International anesthesiology clinics, 1972,Spring, Volume: 10, Issue:1

    Topics: Ammonia; Bacterial Infections; Blood Circulation; Blood Group Incompatibility; Citrates; Embolism, A

1972
Studies on the blood composition of hyperthermic animals.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1970, May-02, Volume: 44, Issue:18

    Topics: Ammonia; Aorta; Bicarbonates; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Carbon Dio

1970
Reye's syndrome: ammonia intoxication as a possible factor in the encephalopathy.
    Pediatrics, 1969, Volume: 43, Issue:3

    Topics: Adolescent; Ammonia; Brain Diseases; Child; Child, Preschool; Coma; Dermatitis; Fatty Liver; Female;

1969