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A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With Wiskott-Aldrich Syndrome

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date changed from estimate of Sep 2025 to Mar 18, 2024v15
  2. Lead sponsor: Orchard Therapeutics to Fondazione Telethonv14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary completion date: Jul 2023 to Sep 2025
    • Study completion date: Jan 2024 to Sep 2027
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 6 entries
    v12
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 1 to 2v10
  2. Enrollment target: 9 to 10v9
  3. Trial status: Active, Not Recruiting to Recruitingv8 Show 4 more changesShow less
    • Enrollment target: 6 to 9
    • Primary completion date: Feb 2022 to Jul 2023
    • Study completion date: Dec 2022 to Jan 2024
    • Site details revised
  4. Phase: Phase 2 to Phase 3
    • Primary endpoints: 1 to 2
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 4 to 6
    v7
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  6. Site contact updatedv5
  7. Re-verified, no change to tracked fieldsv4
  8. Phase: Phase 1/2 to Phase 2v3
  9. Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (4)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, single arm study to evaluate the cryopreserved formulation of OTL-103 Gene Therapy. OTL-103 consists of autologous CD34+ hematopoietic stem cells in which the gene encoding for the Wiskott-Aldrich Syndrome is introduced by means of a third generation lentiviral vector.
Trial Details
NCT Number NCT03837483
Lead Sponsor Fondazione Telethon
Collaborators: Ospedale San Raffaele
Conditions
(from sponsor)		 Wiskott-Aldrich Syndrome
Related terms Wiskott-Aldrich Syndrome
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov