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Registry Study of Revcovi Treatment in Patients With ADA-SCID

About

Brief Summary

This registry is conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) treated with Revcovi™ to collect periodic clinical and biochemical data on safety and dose adjustment.

Study Type
observational_patient_registry
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
0 Months
Maximum Age
65 Years

Inclusion Criteria:

  • Patients currently receiving chronic ERT with Adagen® and transitioned/transitioning to Revcovi;
  • Infants diagnosed via newborn screening and definitive testing for ADA deficiency prescribed Revcovi;
  • Patients receiving Revcovi while preparing for Hematopoietic Stem Cell Transplant (HSCT) or Hematopoietic Stem Cell Gene Therapy (HSCGT)
  • Patients who decline, are ineligible or do not respond to HSCT or HSC-GT and resume/start Revcovi.

Exclusion Criteria:

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

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Study Stats
Protocol No.
19-000797
Category
Pediatrics
Contact
Alexis Stephens
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03878069
For detailed technical eligibility, visit ClinicalTrials.gov.