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.
Excerpt | Relevance | Reference |
---|---|---|
" 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." | 7.79 | Does 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." | 3.79 | Does 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." | 1.46 | Safety 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." | 1.38 | Peripheral 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." | 1.29 | Factors 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." | 1.29 | Balloon-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." | 1.28 | Brain 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." | 1.28 | Emergency department laboratory evaluation of children with seizures: dogma or dilemma? ( Davis, AT; Nypaver, MM; Reynolds, SL; Tanz, RR, 1992) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 9 (45.00) | 18.7374 |
1990's | 5 (25.00) | 18.2507 |
2000's | 1 (5.00) | 29.6817 |
2010's | 5 (25.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Berry, SA | 1 |
Longo, N | 1 |
Diaz, GA | 1 |
McCandless, SE | 1 |
Smith, WE | 1 |
Harding, CO | 1 |
Zori, R | 1 |
Ficicioglu, C | 1 |
Lichter-Konecki, U | 1 |
Robinson, B | 1 |
Vockley, J | 1 |
Northrop, NA | 1 |
Halpin, LE | 2 |
Yamamoto, BK | 2 |
Orton, DJ | 1 |
Gifford, JL | 1 |
Seiden-Long, I | 1 |
Khan, A | 1 |
de Koning, L | 1 |
Good, P | 1 |
CONSTANTSAS, NS | 1 |
DANELATOU-ATHANASSIADOU, C | 1 |
Burgery, FJ | 1 |
Fuhrman, FA | 1 |
Linnane, DM | 1 |
Bracken, RM | 1 |
Brooks, S | 1 |
Cox, VM | 1 |
Ball, D | 1 |
Muñoz, SJ | 1 |
Moritz, MJ | 1 |
Bell, R | 1 |
Northrup, B | 1 |
Martin, P | 1 |
Radomski, J | 1 |
Koito, K | 1 |
Namieno, T | 1 |
Nagakawa, T | 1 |
Morita, K | 1 |
Hinnie, J | 1 |
Colombo, JP | 1 |
Wermuth, B | 1 |
Dryburgh, FJ | 1 |
Goldberg, RN | 1 |
Cabal, LA | 1 |
Sinatra, FR | 1 |
Plajstek, CE | 1 |
Hodgman, JE | 1 |
Kruckenberg, SM | 1 |
Cook, JE | 1 |
Feldman, BF | 1 |
Robinson, MB | 1 |
Anegawa, NJ | 1 |
Gorry, E | 1 |
Qureshi, IA | 1 |
Coyle, JT | 1 |
Lucki, I | 1 |
Batshaw, ML | 1 |
Nypaver, MM | 1 |
Reynolds, SL | 1 |
Tanz, RR | 1 |
Davis, AT | 1 |
Jacob, S | 1 |
Holm, E | 1 |
Fischer, B | 1 |
Burger, FJ | 2 |
Du Plessis, JP | 1 |
Bieler, EU | 1 |
Lategan, PJ | 1 |
Hossaini, AA | 1 |
Boyan, CP | 1 |
Engelbrecht, FM | 1 |
Jordaan, EM | 1 |
Bester, P | 1 |
Huttenlocher, PR | 1 |
Schwartz, AD | 1 |
Klatskin, G | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 4 | 27 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 100 |
"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
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 100 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1321.18 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 246.126 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 115.3 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 98.98 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 4.197 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.85 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 7.422 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1384.12 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 583.835 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 102.1 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 69.39 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 20.62 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 11.72 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 6.573 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 280.936 |
(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
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 374.53 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 46.2 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 4.8 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 1.697 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 8.383 |
(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
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.39 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 36.52 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 62.45 |
(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
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 42.44 |
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
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 0.003 |
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
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 0.005 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 84.97 | 26.81 | 25.16 | 50.05 | 18.77 | 57.43 | 43.65 | 33.41 | 8.75 | 25.75 | 2.50 | 16.10 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 122.43 | -54.50 | 7.80 | -16.33 | -13.00 | 0.25 | -2.20 | 30.80 | 22.20 | 39.00 | 48.00 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 508.83 | 21.04 | -27.62 | -15.09 | -113.98 | -99.82 | -138.16 | -56.08 | -181.50 | -103.75 | -184.00 | -219.93 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 750.43 | -184.33 | -174.60 | -374.00 | -252.75 | -370.25 | -113.20 | -446.53 | -450.50 | -149.00 | 195.00 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 142.68 | -49.09 | -1.62 | -20.46 | -67.32 | -75.45 | -35.94 | -73.09 | -178.50 | -139.50 | 1.00 | -55.31 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 54.86 | 2.67 | 4.20 | -25.67 | -20.25 | -20.00 | -16.40 | -6.73 | -13.33 | -18.00 | 1.50 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 133.67 | -81.91 | -60.80 | -51.66 | -82.82 | -118.55 | -11.85 | -115.09 | -249.50 | -195.75 | 6.00 | -82.54 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 90.86 | -0.83 | 9.80 | -33.00 | -31.25 | -39.50 | -25.40 | -19.13 | -34.37 | -40.00 | -1.50 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 593.80 | 47.85 | -2.46 | 34.96 | -95.21 | -42.39 | -94.51 | -22.66 | -172.75 | -78.00 | -181.50 | -203.83 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 872.86 | -238.83 | -166.80 | -390.33 | -265.75 | -370.00 | -115.40 | -415.73 | -428.30 | -110.00 | 243.00 |
(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
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 181.49 | -63.96 | -39.04 | -23.86 | -74.41 | -98.67 | 2.64 | -90.40 | -238.25 | -137.00 | 38.00 | -72.78 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 171.43 | 4.00 | 40.60 | -27.33 | -31.50 | -56.00 | -21.60 | -11.90 | -48.87 | -46.00 | 5.00 |
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
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.0544 | -0.2158 | -0.2598 | -0.1617 | -0.0264 | 0.0828 | 0.0136 | 0.4614 | 0.6646 | 0.6830 | 0.3308 | 0.7743 |
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
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.8107 | -0.2385 | -0.0249 | 0.1815 | 0.4434 | 0.1484 | 0.2497 | 0.6407 | 0.4164 | -0.2997 | -0.2038 | 0.5581 |
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
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.7143 | -0.2105 | -0.0704 | 0.1065 | 0.3365 | 0.1043 | 0.1842 | 0.4875 | 0.2944 | -0.3661 | -0.2214 | 0.4310 |
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
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.1980 | 0.2336 | 0.2006 | 0.2684 | 0.2372 | 0.1810 | 0.2902 | 0.1679 | 0.1308 | 0.1595 | 0.1050 | 0.7341 |
(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
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 11.1 | 46.2 | 62.5 | 34.6 | 22.8 | 35.2 |
(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
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 18.78 | 6.50 | 7.29 | 2.60 | 4.48 | 4.31 |
(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)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 23.7 | 14.6 | 12.3 | 14.4 | 6.4 | 13.2 | 5.5 | 11.8 | 6.0 | 4.9 | 11.6 |
(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)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 15 | Month 18 | End of trial | |
RAVICTI: Age 2 Months to < 2 Years | 5.82 | 4.44 | 3.69 | 4.65 | 7.14 | 3.27 | 1.59 | 4.10 | 2.04 | 1.64 | 7.0 |
(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
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 3530.43 | 1828 | 1746 | 2260 | 3530.43 | 4404 |
(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
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 3273 | 4140 | 3145 | 5202 | 3950 | 7561 |
(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)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 4643 | 4517 | 4116 | 7037 | 2826 | 6973 | 5883 | 7006 | 5847 | 3915 | 6939 |
(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)
Intervention | μg/mL (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |
RAVICTI: Age 2 Months to < 2 Years | 8859 | 6274 | 7386 | 11456 | 21416 | 6129 | 5347 | 9357 | 2580 | 6400 | 5250 | 25333 |
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).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 0 to < 2 Months | 16 | 10 | 11 | 0 | 0 | 1 |
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).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 2 Months to < 2 Years | 10 | 4 | 6 | 0 | 1 | 1 |
1 trial available for ammonium hydroxide and Fever
Article | Year |
---|---|
Effects of hyperthermia on the metabolic responses to repeated high-intensity exercise.
Topics: Adult; Ammonia; Body Temperature; Energy Metabolism; Energy Transfer; Fever; Humans; Lactic Acid; Ma | 2004 |
19 other studies available for ammonium hydroxide and Fever
Article | Year |
---|---|
Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years.
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.
Topics: Ammonia; Animals; Blood-Brain Barrier; Capillaries; Capillary Permeability; Central Nervous System S | 2016 |
Critically High Plasma Ammonia in an Adolescent Girl.
Topics: Ammonia; Arginine; Child; Clinical Chemistry Tests; Diagnostic Errors; Fatigue; Female; Fever; Heada | 2016 |
Peripheral ammonia as a mediator of methamphetamine neurotoxicity.
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?
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.
Topics: Adolescent; Amino Acid Metabolism, Inborn Errors; Amino Acids; Ammonia; Body Fluids; Child; Collagen | 1964 |
EVIDENCE OF INJURY TO TISSUES AFTER HYPERTHERMIA.
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.
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.
Topics: Ammonia; Bilirubin; Blood Urea Nitrogen; Catheterization; Collateral Circulation; Contrast Media; Cr | 1996 |
N-Acetylglutamate synthetase deficiency responding to carbamylglutamate.
Topics: Acetyltransferases; Amino-Acid N-Acetyltransferase; Ammonia; Brain Diseases; Consanguinity; Fever; G | 1997 |
Hyperammonemia associated with perinatal asphyxia.
Topics: Ammonia; Asphyxia Neonatorum; Female; Fever; Follow-Up Studies; Heart Rate; Hepatic Encephalopathy; | 1979 |
Clinical toxicities of pet and caged rodents and rabbits.
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.
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?
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.
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.
Topics: Amino Acids; Ammonia; Animals; Body Temperature; Capillary Permeability; Endothelium; Fever; Hot Tem | 1972 |
Transfusion reactions.
Topics: Ammonia; Bacterial Infections; Blood Circulation; Blood Group Incompatibility; Citrates; Embolism, A | 1972 |
Studies on the blood composition of hyperthermic animals.
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.
Topics: Adolescent; Ammonia; Brain Diseases; Child; Child, Preschool; Coma; Dermatitis; Fatty Liver; Female; | 1969 |