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

Hyperargininemia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03378531
Study type	Interventional
Source	Aeglea Biotherapeutics
Contact
Status	Completed
Phase	Phase 2
Start date	December 7, 2017
Completion date	December 15, 2022

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Recruiting	`NCT04612764` - Liver Disease in Urea Cycle Disorders
Completed	`NCT02488044` - A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency	Phase 1/Phase 2
Recruiting	`NCT04908319` - Hepatic Histopathology in Urea Cycle Disorders
Terminated	`NCT01421888` - The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity
Terminated	`NCT05676853` - A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency	Phase 3
Completed	`NCT03921541` - Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency	Phase 3