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Evaluation of the Safety, Tolerability and Efficacy of a Gene Therapy Drug for the Treatment of Pediatric Fabry Disease

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 9, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2024 to Feb 20, 2024
    • Site details revised
    v3
  2. Primary endpoints: 3 to 2
    • Start date: Jan 2024 to Feb 2024
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single-arm, open label, single-dose clinical study to evaluate the safety, tolerability and efficacy of BBM-F101 injection in the pediatric Fabry disease participants up to 52 weeks after infusion, and the long-term safety and efficacy of BBM-F101 injection up to 5 years after infusion. BBM-F101 injection is an adeno-associated virus (AAV) gene therapy product for the treatment of pediatric Fabry disease.
Trial Details
NCT Number NCT06207552
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Fabry Disease
Related terms Fabry Disease
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov