Registry Study of Revcovi Treatment in Patients With ADA-SCID

Completed

Conditions studied: Adenosine Deaminase Severe Combined Immunodeficiency

In brief

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.

Key facts

Study ID

NCT03878069

Run by

Chiesi Farmaceutici S.p.A.

People needed

32

Starts

2019-09-30

Expected to finish

2023-01-18

Last updated by the study team

2024-11-15

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any condition that, in the opinion of the Investigator, makes the patient unsuitable for the study.

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• Allergy & Asthma Medical Group and Research Center, A P.C. — San Diego, California, United States
• UCSF - University of California — San Francisco, California, United States
• Children's National — Washington D.C., District of Columbia, United States
• University of South Florida Allergy Immunology Clinic — St. Petersburg, Florida, United States
• Childrens Hospital of New Orleans — New Orleans, Louisiana, United States
• Children's Minnesota — Minneapolis, Minnesota, United States
• St. Louis Children's Hospital - Washington University School of Medicine — St Louis, Missouri, United States
• UBMD Pediatrics Outpatient Center — Buffalo, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Penn State Children's Hospital — Hershey, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Seattle Children's — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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