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Trial record 3 of 3 for:    pegzilarginase

A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency (AEB1102)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03378531
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Aeglea Biotherapeutics

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.

Condition or disease Intervention/treatment Phase
Arginase I Deficiency Hyperargininemia Drug: AEB1102 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: AEB1102
Each patient may receive AEB1102 administered IV for up to approximately 3 years.
Drug: AEB1102
modified human arginase I
Other Names:
  • Co-ArgI-PEG
  • Pegzilarginase




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Cmax Cmin [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing
  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:

1. Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378531


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Texas
UTSW
Dallas, Texas, United States, 75390
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Portugal
Centro Hospitalar S. Joao
Porto, Portugal
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Sponsors and Collaborators
Aeglea Biotherapeutics
Investigators
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Study Director: Josie Gayton Aeglea Biotherapeutics, Inc.

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Responsible Party: Aeglea Biotherapeutics
ClinicalTrials.gov Identifier: NCT03378531     History of Changes
Other Study ID Numbers: CAEB1102-102A
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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

Additional relevant MeSH terms:
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Hyperargininemia
Urea Cycle Disorders, Inborn
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases