A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency
NCT ID: NCT03378531
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2017-12-07
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AEB1102
Each patient may receive AEB1102 administered IV for up to approximately 4 years.
AEB1102
modified human arginase I
Interventions
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AEB1102
modified human arginase I
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient to continue dosing with AEB1102
3. If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
4. 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
5. 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
2 Years
ALL
No
Sponsors
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Aeglea Biotherapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Cortney Caudill
Role: STUDY_DIRECTOR
Aeglea Biotherapeutics, Inc.
Locations
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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
Countries
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References
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Diaz GA, Schulze A, McNutt MC, Leao-Teles E, Merritt JL 2nd, Enns GM, Batzios S, Bannick A, Zori RT, Sloan LS, Potts SL, Bubb G, Quinn AG. Clinical effect and safety profile of pegzilarginase in patients with arginase 1 deficiency. J Inherit Metab Dis. 2021 Jul;44(4):847-856. doi: 10.1002/jimd.12343. Epub 2021 Jan 26.
Other Identifiers
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CAEB1102-102A
Identifier Type: -
Identifier Source: org_study_id
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