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Gene Therapy for Severe Crigler Najjar Syndrome

Study acronym: CareCN
StatusRecruiting
PhaseNot applicable
SponsorGenethon
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 28, 2023 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 20, 2022 to Mar 30, 2026
    • Primary endpoints revised (2)
    • Study completion date: Dec 27, 2026 to Mar 30, 2030
    • Secondary endpoints revised (2)
    v7
  2. Primary completion date: Oct 20, 2021 to Jun 20, 2022
    • Study completion date: Apr 27, 2026 to Dec 27, 2026
    v6
  3. Primary completion date: Dec 31, 2020 to Oct 20, 2021
    • Study completion date: Dec 31, 2020 to Apr 27, 2026
    • Secondary endpoints: 1 to 2
    v5
  4. Phase: Phase 1/2 to Not applicablev4
  5. Primary and study completion dates: Aug 31, 2020 to Dec 31, 2020
    • Site details revised at 1 of 4 sites
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Genethon
9 trials monitored
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This is a Phase 1/2, multinational, open-label, study to evaluate the safety and efficacy of an intravenous infusion of GNT0003 in patients with Crigler-Najjar aged ≥10 years and requiring phototherapy. Patients will received a single administration of GNT0003 and will be followed for safety and efficacy of approximately 60 months (5 years): * a follow-up of approximately 12 months (48 weeks) * a long term follow-up of approximately 48 months (4 years), in order to be in line with the latest EMEA Guideline on follow-up of patients administered with gene therapy medicinal products, released on 22 Oct.2009 by the Committee for medicinal products for human use.
Trial Details
NCT Number NCT03466463
Lead Sponsor Genethon
Conditions
(from sponsor)		 Crigler-Najjar Syndrome
Related terms Crigler-Najjar Syndrome
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov