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

NCT03378531 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Arginase I Deficiency
  • Hyperargininemia

Interventions

DRUG

AEB1102

modified human arginase I

Sponsors & Collaborators

  • Aeglea Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Cortney Caudill · Aeglea Biotherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2022-12-15
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378531 on ClinicalTrials.gov