NCT03378531

A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency

An Open-label, Multicentre Extension Study to Evaluate the Long-Term Safety, Tolerability and Effects of Intravenous AEB1102 in Patients With Arginase I Deficiency Who Previously Received Treatment in Study CAEB1102-101A

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Aeglea Biotherapeutics · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

Detailed description

Purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

Conditions

• Arginase I Deficiency
• Hyperargininemia

Interventions

Type	Name	Description
DRUG	AEB1102	modified human arginase I

Timeline

• Start date: 2017-12-07
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2017-12-20
• Last updated: 2023-07-27

Locations

7 sites across 4 countries: United States, Canada, Portugal, United Kingdom

Regulatory

• FDA-regulated drug study