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FIX LONG STUDY: A FACTOR IX (FIX) GENE TRANSFER, MULTI CENTER EVALUATION OF THE LONG TERM SAFETY AND EFFICACY STUDY OF SPK 9001 (RAAV SPARK100 HFIX PADUA) IN INDIVIDUALS WITH HEMOPHILIA B

Trial Profile

FIX LONG STUDY: A FACTOR IX (FIX) GENE TRANSFER, MULTI CENTER EVALUATION OF THE LONG TERM SAFETY AND EFFICACY STUDY OF SPK 9001 (RAAV SPARK100 HFIX PADUA) IN INDIVIDUALS WITH HEMOPHILIA B

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Fidanacogene-elaparvovec (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions
  • Acronyms FIX-LONG Study
  • Sponsors Pfizer; Spark Therapeutics
  • Most Recent Events

    • 02 Dec 2019 Planned End Date changed from 8 Jun 2026 to 6 Oct 2026.
    • 02 Dec 2019 Planned primary completion date changed from 8 Jun 2026 to 6 Oct 2026.
    • 10 Aug 2019 Planned End Date changed from 16 May 2026 to 8 Jun 2026.
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