glycerol and Hyperammonemia

glycerol has been researched along with Hyperammonemia in 6 studies

Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.

Hyperammonemia: Elevated level of AMMONIA in the blood. It is a sign of defective CATABOLISM of AMINO ACIDS or ammonia to UREA.

Research

Studies (6)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0

"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).~The WH criteria are widely used for rating the severity of HE and are summarized below:~Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)~Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:~Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps" (NCT00999167)
Timeframe: Part B: 112 Days

Time to Meeting the Primary Endpoint

Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1. (NCT00999167)
Timeframe: 112 Days

Total Number of HE Events

Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms. (NCT00999167)
Timeframe: 112 Days

Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better. (NCT00999167)
Timeframe: Day 56, Final Visit (D112)

Part A: The Rate of AEs and Tolerability of HPN-100

Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms. (NCT00999167)
Timeframe: Part A: 28 days

Reviews

1 review available for glycerol and Hyperammonemia

Trials

2 trials available for glycerol and Hyperammonemia

Other Studies

3 other studies available for glycerol and Hyperammonemia