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

Hyperargininemia Clinical Trial

Official title:
A Phase 3 Open-Label Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05676853
Study type	Interventional
Source	Aeglea Biotherapeutics
Contact
Status	Terminated
Phase	Phase 3
Start date	April 4, 2023
Completion date	April 27, 2023

View Details

See also
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Recruiting	`NCT04908319` - Hepatic Histopathology in Urea Cycle Disorders
Completed	`NCT03378531` - A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency	Phase 2
Terminated	`NCT01421888` - The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity
Completed	`NCT03921541` - Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency	Phase 3