Lentiviral FVIII Gene Therapy

StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later May 31, 2027 → May 31, 2028
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Record History

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  1. Primary completion pushed from May 31, 2027 to May 31, 2028v10 Show 5 more changesShow less
    • Start date: Jun 1, 2025 to Jun 1, 2027
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Study completion pushed from Jun 1, 2028 to Dec 1, 2028
    • Study description expanded, about 66 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: May 31, 2022 to May 31, 2027
    • Start date changed from estimate of Jun 1, 2020 to Jun 1, 2025
    • Study completion date: Jun 1, 2022 to Jun 1, 2028
    • Site details revised
  4. Phase: Phase 1/2 to Phase 1v7 Show 9 more changesShow less
    • Primary completion date: Dec 31, 2020 to May 31, 2022
    • Start date: Jul 15, 2018 to Jun 1, 2020
    • Study completion date: Dec 31, 2021 to Jun 1, 2022
    • Interventions: YUVA-GT-F801 (Biological), YUVA-GT-F901 (Biological) to YUVA-GT-F801 (Biological)
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoint revised
    • Study description shortened, about 26 words
    • Study arms: 2 to 1
    • Study title shortened, about 5 words
  5. Start date: Jul 15, 2017 to Jul 15, 2018v6 Show 5 more changesShow less
    • Trial status: Enrolling by Invitation to Not Yet Recruiting
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 27 words
    • Study title revised
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Dec 31, 2019 to Dec 31, 2020
    • Study completion date: Dec 31, 2020 to Dec 31, 2021
    v5
  2. 2 versions Re-verified since Sep 30, 2017, no change to tracked fieldsv3-v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv2
  1. Study First Submitted
  • 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.
This study is a Phase I trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor VIII into patients with hemophilia A, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.
Trial Details
NCT Number NCT03217032
Lead Sponsor Shenzhen Geno-Immune Medical Institute
Conditions
(from sponsor)		 Hemophilia A
Related terms Hemophilia A
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov