- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378531
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency (AEB1102)
July 25, 2023 updated by: Aeglea Biotherapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Porto, Portugal
- Centro Hospitalar S. Joao
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London, United Kingdom
- Great Ormond Street Hospital
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Texas
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Dallas, Texas, United States, 75390
- UTSW
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
1. Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AEB1102
Each patient may receive AEB1102 administered IV for up to approximately 4 years.
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modified human arginase I
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-related adverse events
Time Frame: up to 4 years
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Incidence of treatment-related adverse events
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up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax Cmin
Time Frame: up to 4 years
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Cmax Cmin
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up to 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cortney Caudill, Aeglea BioTherapeutics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2017
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (Actual)
December 20, 2017
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAEB1102-102A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on AEB1102
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Aeglea BiotherapeuticsTerminatedArginase I Deficiency | HyperargininemiaCanada
-
Aeglea BiotherapeuticsCompletedArginase I Deficiency | HyperargininemiaUnited States, Italy, Canada, France, United Kingdom, Austria, Germany
-
Aeglea BiotherapeuticsCompletedAcute Myeloid Leukemia | Myelodysplastic SyndromeUnited States, Canada
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Aeglea BiotherapeuticsMerck Sharp & Dohme LLCCompletedSmall-cell Lung CancerUnited States, Puerto Rico
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Thammasat UniversityCompleted