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NCT06833983

To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revisedv4
  2. Study sites: 12 to 13v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 11 to 12
    • Start date changed from estimate of Mar 20, 2025 to Mar 31, 2025
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Annualized Bleeding Rate (ABR)
Timeframe: Weeks 3 to 52 after infusion

Secondary (3)

Incidence of adverse events (AE)
Immunogenic response of AAV8 capsid protein and vector derived FVIII within 52 weeks after GS1191-0445 infusion
Evaluate the long-term efficacy of GS1191-0445 injection after intravenous infusion for 2-5 years

Arms and interventions

3E12 vg/kgExperimental

Drugs: GS1191-0445 injection

Sites

13 sites in 1 country