Status:
COMPLETED
Registry Study of Revcovi Treatment in Patients With ADA-SCID
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Adenosine Deaminase Severe Combined Immunodeficiency
Eligibility:
All Genders
Up to 65 years
Brief 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 sa...
Detailed Description
Patients with ADA-SCID who require ERT will receive Revcovi on a dosage and schedule determined by the treating physician. They will be followed for safety throughout the study, and will be monitored ...
Eligibility Criteria
Inclusion
- 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
- Any condition that, in the opinion of the Investigator, makes the patient unsuitable for the study.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03878069
Start Date
September 30 2019
End Date
January 18 2023
Last Update
November 15 2024
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Los Angeles
Los Angeles, California, United States, 90095-1752
2
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States, 92123
3
UCSF - University of California
San Francisco, California, United States, 94158
4
Children's National
Washington D.C., District of Columbia, United States, 20010