glycerol and Pyrexia
glycerol has been researched along with Pyrexia in 15 studies
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Research Excerpts
| Excerpt | Relevance | Reference |
|---|---|---|
| " 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) |
| "During the first trial (dehydration, DE), they cycled until volitional exhaustion (135 +/- 4 min, mean +/- s." | 1.30 | Metabolic and thermodynamic responses to dehydration-induced reductions in muscle blood flow in exercising humans. ( Calbet, JA; González-Alonso, J; Nielsen, B, 1999) |
Research
Studies (15)
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 7 (46.67) | 18.7374 |
| 1990's | 2 (13.33) | 18.2507 |
| 2000's | 4 (26.67) | 29.6817 |
| 2010's | 2 (13.33) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| 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 |
| Takeyasu, Y | 1 |
| Yamane, GY | 1 |
| Tonogi, M | 1 |
| Watanabe, Y | 1 |
| Nishikubo, S | 1 |
| Serita, R | 1 |
| Imura, K | 1 |
| VARGA, L | 1 |
| Monda, M | 1 |
| Viggiano, A | 2 |
| Fuccio, F | 1 |
| De Luca, V | 1 |
| Molnar, D | 2 |
| Milner, RD | 1 |
| González-Alonso, J | 1 |
| Calbet, JA | 1 |
| Nielsen, B | 1 |
| de L Costello, AM | 1 |
| Pal, DK | 1 |
| Manandhar, DS | 1 |
| Rajbhandari, S | 1 |
| Land, JM | 1 |
| Patel, N | 1 |
| Vanuxem, P | 1 |
| Vanuxem, D | 1 |
| Raharison, L | 1 |
| Aubert, M | 1 |
| Pouliquen, G | 1 |
| Deslangles, O | 1 |
| Popovsky, MA | 1 |
| Matuszek, M | 1 |
| Chambrier, C | 1 |
| Mercatello, A | 1 |
| Tognet, E | 1 |
| Cottet-Emard, JM | 1 |
| Cohen, R | 1 |
| Blay, JY | 1 |
| Favrot, M | 1 |
| Philip, T | 1 |
| Beylot, M | 1 |
| Székely, M | 1 |
| White, FP | 1 |
| White, SR | 1 |
| Matsaniotis, N | 1 |
| Pastelis, V | 1 |
| Agathopoulos, A | 1 |
| Constantsas, N | 1 |
| CHATTERJEE, KN | 1 |
Clinical Trials (1)
Trial Overview
| 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] | |||||||
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
| Intervention | percentage of participants (Number) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 100 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 100 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 1321.18 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 246.126 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 115.3 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 98.98 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 4.197 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 9.85 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 7.422 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 1384.12 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 583.835 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 102.1 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 69.39 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 20.62 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 11.72 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 6.573 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 280.936 |
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
| Intervention | μg*hr/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 374.53 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 46.2 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 4.8 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 1.697 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 8.383 |
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
| Intervention | hours (Mean) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 9.39 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 36.52 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 62.45 |
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
| Intervention | μg/mL (Mean) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 42.44 |
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
| Intervention | HACs per half-year of patient exposure (Number) |
|---|---|
| RAVICTI: Age 0 to < 2 Months | 0.003 |
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
| Intervention | HACs per half-year of patient exposure (Number) |
|---|---|
| RAVICTI: Age 2 Months to < 2 Years | 0.005 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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
| 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 |
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)
| 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 |
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)
| 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 |
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
| 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 |
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
| 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 |
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)
| 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 |
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)
| 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 |
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).
| 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 |
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).
| 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 |
Trials
2 trials available for glycerol and Pyrexia
| Article | Year |
|---|---|
Ventilator-associated pneumonia risk decreased by use of oral moisture gel in oral health care.
Topics: Aged; Aged, 80 and over; Anti-Infective Agents, Local; Biofilms; Coloring Agents; Critical Care; Equ | 2014 |
Maximal exercise and muscle energy metabolism after recovery from exercise hyperthermia syndrome.
Topics: Adult; Blood Pressure; Body Temperature; Central Nervous System Diseases; Convalescence; Creatine Ki | 2001 |
Other Studies
13 other studies available for glycerol and Pyrexia
| 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 |
Observations on the glycerol-extracted musculus psoas of the rabbit at higher temperature.
Topics: Animals; Fever; Glycerol; Hot Temperature; Muscles; Psoas Muscles; Rabbits; Temperature | 1950 |
Injection of orexin A into the diagonal band of Broca induces sympathetic and hyperthermic reactions.
Topics: Action Potentials; Adipose Tissue; Analysis of Variance; Animals; Carrier Proteins; Diagonal Band of | 2004 |
Metabolic and hormonal response to endotoxin fever in fed and starved one-week rabbits.
Topics: Adipose Tissue; Animals; Animals, Newborn; Blood Glucose; Body Temperature; Endotoxins; Fever; Glyce | 1983 |
Metabolic and thermodynamic responses to dehydration-induced reductions in muscle blood flow in exercising humans.
Topics: Adult; Blood Glucose; Body Temperature; Carbon Dioxide; Dehydration; Epinephrine; Exercise; Exercise | 1999 |
Neonatal hypoglycaemia in Nepal 2. Availability of alternative fuels.
Topics: Age Factors; Blood Glucose; Cross-Sectional Studies; Energy Metabolism; Fatty Acids, Nonesterified; | 2000 |
Frozen and washed red blood cells: new approaches and applications.
Topics: Anaphylaxis; Automation; Blood Preservation; Blood-Borne Pathogens; Erythrocyte Transfusion; Erythro | 2001 |
Studies on antilipolytic activity of antipyretics. Part I. Influence of sodium salicylate, acetylsalicylic acid, phenazone, aminophenazone, and acetophenidin on lipolysis in fever induced by E. coli pyrogen.
Topics: Aminopyrine; Analgesics; Animals; Antipyrine; Aspirin; Body Temperature; Escherichia coli; Fatty Aci | 1976 |
Hormonal and metabolic effects of chronic interleukin-2 infusion in cancer patients.
Topics: Adult; Carcinoma, Renal Cell; Epinephrine; Fatty Acids, Nonesterified; Female; Fever; Glycerol; Huma | 1990 |
Metabolic effects of endotoxin in newborn rabbits.
Topics: Acetoacetates; Alanine; Animals; Animals, Newborn; Blood Glucose; Endotoxins; Escherichia coli; Fatt | 1986 |
Effects of polyhydroxyl alcohols on protein synthesis in brain slices.
Topics: Alcohols; Animals; Blood Vessels; Brain; Cerebrovascular Circulation; Fever; Glycerol; Heat-Shock Pr | 1987 |
Fever and biochemical thermogenesis.
Topics: Adolescent; Age Factors; Body Temperature Regulation; Child; Child, Preschool; Fatty Acids, Nonester | 1971 |
The influence of new moon and full moon on malarial fever.
Topics: Fever; Humans; Malaria; Moon | 1945 |