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Long-term Follow-up of Subjects with Sickle Cell Disease Treated with Ex Vivo Gene Therapy

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Study sites: 15 to 16v13
  2. Study sites: 14 to 15v12
  3. Re-verified, no change to tracked fieldsv11
  4. Secondary endpoints: details revised at 2 of 12 entriesv10
  5. Study sites: 12 to 14v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 11 to 12v8
  2. Study sites: 10 to 11v7
  3. Study sites: 9 to 10v6
  4. Study sites: 8 to 9v5
  5. Study sites: 5 to 8v4
  6. Primary and study completion dates: May 2037 to Jan 2038v3 Show 4 more changesShow less
    • Primary endpoints: 1 to 4
    • Study sites: 3 to 5
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints revised (12)
  7. Study sites: 2 to 3v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multi-center, long-term safety and efficacy follow-up study for subjects with sickle cell disease who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.
Trial Details
NCT Number NCT04628585
Lead Sponsor Genetix Biotherapeutics Inc.
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov