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Phase 3, Open-label, Single-arm Study to Evaluate Efficacy and Safety of FIX Gene Transfer With PF-06838435 (rAAV-Spark100-hFIX-R338L) in Adult Male Participants With Moderately Severe to Severe Hemophilia B (FIX:C =2%) (BeneGene-2)

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Trial Profile

Phase 3, Open-label, Single-arm Study to Evaluate Efficacy and Safety of FIX Gene Transfer With PF-06838435 (rAAV-Spark100-hFIX-R338L) in Adult Male Participants With Moderately Severe to Severe Hemophilia B (FIX:C =2%) (BeneGene-2)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2025

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At a glance

  • Drugs Fidanacogene-elaparvovec (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms BENEGENE-2
  • Sponsors Pfizer

Most Recent Events

  • 16 Sep 2025 Planned End Date changed from 25 Feb 2028 to 25 Feb 2031.
  • 04 Jul 2025 Planned End Date changed from 25 Feb 2031 to 25 Feb 2028.
  • 17 Apr 2025 Planned End Date changed from 9 Jan 2031 to 25 Feb 2031.

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