Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

StatusTerminated
PhasePhase 2
SponsorPfizer
Started

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Record History

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  1. Reclassified as terminated (was completed) Sponsor's reason: The study was terminated early due to Sponsor and participants may transition into a long-term follow-up study. The decision to terminate the trial was not based on any safety and/or efficacy concerns. Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Site details revised at 1 of 25 sites
    • Publications: details revised at 3 of 3 entries
  2. Primary completion moved earlier from May 29, 2029 to Jul 23, 2026
    • Trial completed
    • Study completion moved earlier from Oct 25, 2029 to Jul 23, 2026
    v42
  3. Trial sites expanded: 12 → 25 locationsv41
  4. Trial sites reduced: 25 → 12 locationsv40
  5. 2 versions Re-verified since Mar 16, 2026, no change to tracked fieldsv38-v39
Show 36 earlier versionsHide 36 earlier versions
  1. Study sites: 22 to 25
    • Primary completion date: Jun 8, 2029 to May 29, 2029
    • Study completion date: Jun 8, 2029 to Oct 25, 2029
    v37
  2. Re-verified, no change to tracked fieldsv36
  3. Study sites: 28 to 22
    • Primary and study completion dates: Jun 6, 2029 to Jun 8, 2029
    v35
  4. Re-verified, no change to tracked fieldsv34
  5. Primary and study completion dates: May 29, 2029 to Jun 6, 2029v33
  6. 4 versions Re-verified since Jul 16, 2023, no change to tracked fieldsv29-v32
  7. Primary endpoints: 12 to 1v28 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 21
    • Study sites: 26 to 28
    • Primary and study completion dates: Apr 22, 2029 to May 29, 2029
    • Secondary endpoints: 11 to 14
  8. Study sites: 25 to 26v27
  9. Study sites: 22 to 25v26
  10. Study sites: 16 to 22v25
  11. Site details revised at 2 of 16 sitesv24
  12. Study sites: 18 to 16v23
  13. Site details revised at 1 of 18 sitesv22
  14. Study sites: 17 to 18v21
  15. Primary and study completion dates: Sep 29, 2028 to Apr 22, 2029
    • Study sites: 15 to 17
    v20
  16. Primary completion date: Sep 9, 2023 to Sep 29, 2028
    • Study sites: 13 to 15
    • Study completion date: Sep 2, 2028 to Sep 29, 2028
    v19
  17. Primary completion date: May 12, 2028 to Sep 9, 2023
    • Study sites: 12 to 13
    • Study completion date: May 12, 2028 to Sep 2, 2028
    v18
  18. Site details revised at 3 of 12 sitesv17
  19. Study sites: 8 to 12
    • Primary and study completion dates: Jan 25, 2028 to May 12, 2028
    v16
  20. Site details revised at 1 of 8 sitesv15
  21. Study sites: 7 to 8
    • Primary and study completion dates: Nov 10, 2027 to Jan 25, 2028
    v14
  22. Enrollment target: 20 to 55v13 Show 8 more changesShow less
    • Primary and study completion dates: Oct 6, 2026 to Nov 10, 2027
    • Primary endpoints: 1 to 12
    • Interventions: SPK-9001 (Biological) to PF-06838435 (formerly SPK-9001) (Biological)
    • Eligibility criteria shortened, about 45 words
    • Secondary endpoints: 8 to 11
    • Study description expanded, about 51 words
    • Study arms: 0 to 1
    • Study title expanded, about 4 words
  23. Study sites: 6 to 7
    • Primary and study completion dates: Jun 8, 2026 to Oct 6, 2026
    v12
  24. Primary and study completion dates: May 16, 2026 to Jun 8, 2026v11
  25. Primary and study completion dates: Jan 5, 2024 to May 16, 2026
    • Study sites: 8 to 6
    v10
  26. Primary and study completion dates: Dec 29, 2023 to Jan 5, 2024v9
  27. Primary and study completion dates: Mar 30, 2024 to Dec 29, 2023v8
  28. Eligibility criteria expanded, about 159 words
    • Secondary endpoints: 7 to 8
    v7
  29. Site details revised at 1 of 8 sitesv6
  30. Phase: Not specified to Phase 2
    • Primary and study completion dates: Apr 30, 2023 to Mar 30, 2024
    • Enrollment target: 15 to 20
    • Study sites: 7 to 8
    v5
  31. Lead sponsor: Spark Therapeutics, Inc. to Pfizer
    • Study sites: 4 to 7
    • Primary and study completion dates: Apr 2023 to Apr 30, 2023
    • Collaborators shortened, about 1 word
    v4
  32. Study sites: 3 to 4
    • Primary and study completion dates: Mar 2023 to Apr 2023
    • Interventions: SPK-9001 (Genetic) to SPK-9001 (Biological)
    v3
  33. Enrollment target: 11 to 15
    • Site details revised at 1 of 3 sites
    v2
  1. 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
Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.
Trial Details
NCT Number NCT03307980
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Hemophilia B
Related terms Hemophilia A, Hemophilia B
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov