NCT03378531
Completed
Phase 2
An Open-label, Multicentre Extension Study to Evaluate the Long-Term Safety, Tolerability and Effects of Intravenous AEB1102 in Patients With Arginase I Deficiency Who Previously Received Treatment in Study CAEB1102-101A
Aeglea Biotherapeutics7 sites in 4 countries14 target enrollmentDecember 7, 2017
Overview
- Phase
- Phase 2
- Intervention
- AEB1102
- Conditions
- Arginase I Deficiency
- Sponsor
- Aeglea Biotherapeutics
- Enrollment
- 14
- Locations
- 7
- Primary Endpoint
- Incidence of treatment-related adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 CAEB1102-101A.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
Arms & Interventions
AEB1102
Each patient may receive AEB1102 administered IV for up to approximately 4 years.
Intervention: AEB1102
Outcomes
Primary Outcomes
Incidence of treatment-related adverse events
Time Frame: up to 4 years
Incidence of treatment-related adverse events
Secondary Outcomes
- Cmax Cmin(up to 4 years)
Study Sites (7)
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