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Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.

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
    • Enrollment target: estimated 12 to confirmed 8
    v13
  2. Primary and study completion dates: Aug 10, 2037 to Jul 14, 2038
    • Study sites: 6 to 7
    v12
  3. Study sites: 5 to 6v11
  4. Study sites: 4 to 5v10
  5. Study sites: 3 to 4v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 2 to 3v8
  2. Trial status: Recruiting to Enrolling by Invitation
    • Enrollment target: 13 to 12
    • Study sites: 1 to 2
    • Study title shortened, about 14 words
    v7
  3. Lead sponsor: Bioverativ, a Sanofi company to Sangamo Therapeuticsv6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary and study completion dates: Mar 13, 2043 to Aug 10, 2037v4
  6. Start date changed from estimate of Dec 20, 2021 to Dec 21, 2021v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary Objectives: Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT) Secondary Objectives: * Long-term efficacy of the biological treatment effect of BIVV003 in SCD * Long-term efficacy of the clinical treatment effect of BIVV003 on SCD-related clinical events * Long-term efficacy of the biological treatment effect of ST-400 in TDT * Long-term efficacy of the clinical treatment effect of ST-400 in TDT
Trial Details
NCT Number NCT05145062
Lead Sponsor Sangamo Therapeutics
Conditions
(from sponsor)		 Blood and Lymphatic Diseases
Related terms Anemia, Sickle Cell, beta-Thalassemia, Lymphatic Diseases
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov