A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
Completed · Phase 2
Conditions studied: Arginase I Deficiency, Hyperargininemia
In brief
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.
Key facts
- Study ID
- NCT03378531
- Run by
- Aeglea Biotherapeutics
- People needed
- 14
- Starts
- 2017-12-07
- Expected to finish
- 2022-12-15
- Last updated by the study team
- 2023-07-27
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing
- Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient to continue dosing with AEB1102
- If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
- If sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
- Patient or legal guardian is able and willing to provide written informed consent and where required assent, and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification), prior to any screening procedures
You may not qualify if…
- Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
- University of Florida — Gainesville, Florida, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- UTSW — Dallas, Texas, United States
- The Hospital for Sick Children — Toronto, Ontario, Canada
- Centro Hospitalar S. Joao — Porto, Portugal
- Great Ormond Street Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.