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Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date: Oct 30, 2034 to Jan 17, 2034
    • Study completion date: Jan 30, 2035 to Jan 17, 2034
    v3
  2. Primary endpoints revised (7)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial. After completion of the FANCOLEN-I study, eligible subjects will be followed for a total of 15 years post gene therapy treatment. No investigational drug product will be administered during this study.
Trial Details
NCT Number NCT04437771
Lead Sponsor Rocket Pharmaceuticals Inc.
Conditions
(from sponsor)		 Fanconi Anemia Complementation Group A, Fanconi Anemia
Related terms Anemia, Bone Marrow Failure Disorders, Fanconi Anemia, Fanconi Syndrome, Genetic Diseases, Inborn
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov