Status:
COMPLETED
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
Lead Sponsor:
Aeglea Biotherapeutics
Conditions:
Arginase I Deficiency
Hyperargininemia
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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 CAEB1102-101...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 1\. Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03378531
Start Date
December 7 2017
End Date
December 15 2022
Last Update
July 27 2023
Active Locations (7)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
University of Florida
Gainesville, Florida, United States, 32610
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
UTSW
Dallas, Texas, United States, 75390