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NCT03378531 · ClinicalTrials.gov registry record · Phase 2
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
A Phase 2 study of Hyperargininemia and Arginase I Deficiency, sponsored by Aeglea Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 7
- Study locations
NCT03378531: Completed Phase 2 study of Hyperargininemia and Arginase I Deficiency, sponsored by Aeglea Biotherapeutics.
NCT03378531 is a Phase 2 study of Hyperargininemia and Arginase I Deficiency that has completed, run by Aeglea Biotherapeutics. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03378531, a Phase 2 study of Hyperargininemia and Arginase I Deficiency, has completed, sponsored by Aeglea Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Incidence of treatment-related adverse events
Conditions Studied
Interventions
- DRUG AEB1102
Study Locations (7)
Other
- Centro Hospitalar S. Joao - Porto
- Great Ormond Street Hospital - London
California
- Stanford University School of Medicine - Stanford
Florida
- University of Florida - Gainesville
New York
- Icahn School of Medicine at Mount Sinai - New York
Texas
- UTSW - Dallas
Ontario
- The Hospital for Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 2 |
What the finished NCT03378531 record still lists
NCT03378531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Hyperargininemia appearing as the primary indexed condition, and to 1 intervention - of which AEB1102 is the first listed.
NCT03378531 lists 7 locations in 6 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03378531 about?
NCT03378531 is a clinical study titled "A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency". 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.
What is the current status of trial NCT03378531?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2017-12-07. Estimated completion is 2022-12-15.
What conditions does trial NCT03378531 study?
This clinical trial studies the following conditions: Hyperargininemia, Arginase I Deficiency.
What interventions are being tested in trial NCT03378531?
The interventions under investigation include: AEB1102 (DRUG).
Who is sponsoring clinical trial NCT03378531?
This trial is sponsored by Aeglea Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03378531 being conducted?
This trial has 7 study locations across California, Florida, New York, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03378531's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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