Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Site details revised at 1 of 39 sites
  2. Site details revised at 1 of 39 sites
  3. Trial sites expanded: 23 → 39 locations
    • Secondary endpoints: details revised at 6 of 9 entries
    • Publications: details revised at 5 of 5 entries
  4. Study sites: 22 to 23v25
  5. Trial sites expanded: 19 → 22 locationsv24
  6. Trial sites expanded: 8 → 19 locationsv23
  7. Trial sites reduced: 17 → 8 locationsv22
  8. Re-verified, no change to tracked fieldsv21
  9. Study sites: 16 to 17v20
  10. Re-verified, no change to tracked fieldsv19
  11. Enrollment target: 263 to 173
    • Study sites: 12 to 16
    v18
  12. Site details revised at 4 of 12 sitesv17
  13. Study sites: 11 to 12v16
  14. Primary and study completion dates: Sep 3, 2039 to Feb 25, 2040v15
  15. Study sites: 6 to 11v14
  16. Primary and study completion dates: Apr 8, 2038 to Sep 3, 2039
    • Site details revised at 2 of 6 sites
    v13
  17. Site details revised at 1 of 6 sitesv12
  18. Primary and study completion dates: Jan 29, 2038 to Apr 8, 2038v11
  19. Study sites: 5 to 6
    • Primary and study completion dates: Jan 6, 2038 to Jan 29, 2038
    v10
  20. Study sites: 4 to 5
    • Primary and study completion dates: Nov 14, 2037 to Jan 6, 2038
    v9
  21. Study sites: 3 to 4v8
  22. Phase: Not specified to Phase 3
    • Enrollment target: 250 to 263
    • Study sites: 2 to 3
    • Study title shortened, about 2 words
    v7
  23. Study sites: 1 to 2v6
  24. 2 versions Re-verified since Mar 16, 2023, no change to tracked fieldsv4-v5
  25. Primary and study completion dates: Oct 19, 2037 to Nov 14, 2037
    • Start date changed from estimate of Jan 13, 2023 to Dec 28, 2022
    v3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 7, 2034 to Oct 19, 2037
    • Start date: Oct 31, 2022 to Jan 13, 2023
    • Study sites: 0 to 1
    v2
  27. Study First Submitted
  • 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.
Pfizer
438 trials monitored
See 32 trials at risk
Hemophilia
241 trials monitored
See 12 trials at risk
A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.
Trial Details
NCT Number NCT05568719
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Hemophilia A, Hemophilia B
Related terms Hemophilia A, Hemophilia B, Hemorrhage
Enrollment 173 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov