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Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A

Study acronym: GENEr8-JPN
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Mar 2025 to Apr 16, 2025v3
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 4
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in Japanese patients with severe hemophilia A.
Trial Details
NCT Number NCT06224907
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Hemophilia A
Related terms Blood Coagulation Disorders, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders, Genetic Diseases, Inborn, Hematologic Diseases, Hemophilia A, Hemorrhagic Disorders, Hemostatic Disorders
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov