At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency
In Brief
A Phase 3 clinical trial evaluating Pegzilarginase and Placebo for Arginase I Deficiency and Hyperargininemia. Completed, enrolled 32 participants across 32 sites in 7 countries.
Detailed Summary
CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.
Study Details
Timeline
Interventions
Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated
Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated