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Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Secondary endpoints revised (37)v17
  2. 2 versions Re-verified since Mar 25, 2024, no change to tracked fieldsv15-v16
  3. Secondary endpoints revised (37)v14
  4. Secondary endpoints: details revised at 3 of 37 entriesv13
  5. Primary and study completion dates: Mar 2031 to Nov 2035v12 Show 8 more changesShow less
    • Start date: Sep 2013 to Jan 2014
    • Primary endpoints revised (4)
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 94 to confirmed 66
    • Study sites: 13 to 15
    • Eligibility criteria revised
    • Secondary endpoints: 8 to 37
    • Study title expanded, about 1 word
Show 10 earlier versionsHide 10 earlier versions
  1. Primary endpoints: 8 to 4
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints expanded, about 65 words
    • Study title expanded, about 1 word
    v11
  2. Re-verified, no change to tracked fieldsv10
  3. Study sites: 11 to 13v9
  4. Study sites: 10 to 11v8
  5. Study sites: 9 to 10v7
  6. Study sites: 8 to 9
    • Eligibility criteria shortened, about 1 word
    v6
  7. Re-verified, no change to tracked fieldsv5
  8. Enrollment target: 86 to 94
    • Study sites: 7 to 8
    v4
  9. Primary endpoints revised (8)
    • Enrollment target: 71 to 86
    • Study sites: 4 to 7
    v3
  10. Enrollment target: 27 to 71
    • Primary endpoints: 7 to 8
    • Study sites: 6 to 4
    • Study title revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (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 this study.
Trial Details
NCT Number NCT02633943
Lead Sponsor Genetix Biotherapeutics Inc.
Conditions
(from sponsor)		 Transfusion-dependent Beta-Thalassemia
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov