Registry Study of Revcovi Treatment in Patients With ADA-SCID

Study Identifier:
CLI-06814AA1-01
ClinicalTrials.gov Identifier:
NCT03878069
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Unmapped
Available Languages: English
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Study Details

Medical Condition
  • Adenosine Deaminase Severe Combined Immunodeficiency
Study Drug
  • Biological: elapegademase-lvlr
Date
Sep 2019 - Jan 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 0 Months - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male or female, aged newborn to adult
  • In need of ERT treatment due to one of the following circumstances:
  • Waiting to receive a stem cell transplant
  • Previously declined, had been found to be ineligible for, or did not respond to a stem cell transplant
  • Waiting to enrol in a clinical trial on gene therapy, or had been found to be ineligible for or had failed such a trial
  • One of the following histories of ERT treatment:
  • Revcovi only
  • Previously on Adagen but had transitioned to Revcovi
  • Not yet on any ERT but about to start on Revcovi
Exclusion Criteria
  • Any condition that, in the opinion of the Investigator, makes the patient unsuitable for the study.
Healthy Volunteers
No

Protocol Summary

This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi. Data on safety and on measures of efficacy are collected.

Study Locations

Location
Status
Location
University of California Los Angeles
Los Angeles, California, United States, 90095-1752
Status
N/A
Location
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States, 92123
Status
N/A
Location
UCSF - University of California
San Francisco, California, United States, 94158
Status
N/A
Location
Children's National
Washington D.C., District of Columbia, United States, 20010
Status
N/A
Location
University of South Florida Allergy Immunology Clinic
St. Petersburg, Florida, United States, 33701
Status
N/A
Location
Childrens Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
Status
N/A
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