drugset / Trial / NCT05676853

A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency

NCT05676853

Phase 3 Terminated 3 enrolled Aeglea Biotherapeutics
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Timeline

Start
2023-04-04
Primary completion
2023-04-27
Completion
2023-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegzilarginase Protein / enzyme biologic Subcutaneous

Indications