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A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
NCT03378531 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03378531
The ClinicalTrials.gov registry entry for NCT03378531 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aeglea Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03378531 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03378531?
The interventions under investigation include: AEB1102 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03378531?
This trial is sponsored by Aeglea Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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