NCT05676853

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Aeglea Biotherapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arginase I Deficiency
• Hyperargininemia

Interventions

Type	Name	Description
DRUG	Pegzilarginase	Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-04-27
• Completion: 2023-04-27
• First posted: 2023-01-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study