A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

Study acronym: BENEGENE-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

The 50 most recent of 61 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion moved earlier from Feb 25, 2031 to Feb 25, 2028 Show 5 more changesShow less
    • Study sites: 67 to 65
    • Interventions: PF-06838435/ fidanacogene elaparvovec (Biological) to PF-06838435/ fidanacogene elaparvovec (Biological)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 12 of 26 entries
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 66 to 67v60
  3. Study sites: 65 to 66v59
  4. 2 versions Re-verified since Apr 1, 2026, no change to tracked fieldsv57-v58
  5. Study sites: 60 to 65v56
Show 44 earlier versionsHide 44 earlier versions
  1. Enrollment target: 72 to 51v55
  2. Enrollment target: 51 to 72
    • Study completion date: Feb 25, 2028 to Feb 25, 2031
    v54
  3. Re-verified, no change to tracked fieldsv53
  4. Study completion date: Feb 25, 2031 to Feb 25, 2028v52
  5. Study sites: 64 to 60
    • Study completion date: Jan 9, 2031 to Feb 25, 2031
    v51
  6. Re-verified, no change to tracked fieldsv50
  7. Study completion date: Dec 5, 2030 to Jan 9, 2031v49
  8. Study sites: 63 to 64
    • Study completion date: Nov 14, 2030 to Dec 5, 2030
    v48
  9. Study sites: 59 to 63
    • Study completion date: Oct 30, 2030 to Nov 14, 2030
    v47
  10. Re-verified, no change to tracked fieldsv46
  11. Study sites: 56 to 59
    • Study completion date: Sep 5, 2030 to Oct 30, 2030
    v45
  12. Study sites: 54 to 56
    • Study completion date: Jul 4, 2030 to Sep 5, 2030
    v44
  13. Re-verified, no change to tracked fieldsv43
  14. Results first posted: Mar 27, 2024
    • Study sites: 52 to 54
    • Study completion date: Mar 27, 2030 to Jul 4, 2030
    • Secondary endpoints: details revised at 10 of 26 entries
    v42
  15. Primary endpoint revisedv41 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 51
    • Study sites: 55 to 52
    • Secondary endpoints: 21 to 26
  16. Study sites: 54 to 55v40
  17. Enrollment target: 55 to 50
    • Study sites: 52 to 54
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (21)
    v39
  18. Study sites: 50 to 52v38
  19. Study sites: 48 to 50v37
  20. Study sites: 47 to 48
    • Study completion date: Mar 30, 2030 to Mar 27, 2030
    v36
  21. Study sites: 44 to 47
    • Study completion date: Dec 18, 2029 to Mar 30, 2030
    v35
  22. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 45 to 55
    • Study sites: 41 to 44
    • Study completion date: Jun 6, 2030 to Dec 18, 2029
    v34
  23. Study sites: 39 to 41v33
  24. Study sites: 40 to 39
    • Study completion date: Mar 11, 2030 to Jun 6, 2030
    v32
  25. Primary completion date: Nov 21, 2022 to Nov 16, 2022v31
  26. Primary completion date: Nov 14, 2022 to Nov 21, 2022
    • Study completion date: Mar 17, 2030 to Mar 11, 2030
    v30
  27. Primary endpoints: 2 to 1v29 Show 5 more changesShow less
    • Enrollment target: 43 to 45
    • Study sites: 41 to 40
    • Primary completion date: Nov 21, 2022 to Nov 14, 2022
    • Study completion date: Dec 14, 2029 to Mar 17, 2030
    • Secondary endpoints: 20 to 21
  28. Study sites: 42 to 41
    • Study completion date: Nov 30, 2029 to Dec 14, 2029
    v28
  29. Study completion date: Oct 25, 2029 to Nov 30, 2029v27
  30. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 43
    • Study sites: 45 to 42
    • Study completion date: Sep 30, 2029 to Oct 25, 2029
    v26
  31. Study completion date: Jul 5, 2029 to Sep 30, 2029v25
  32. Study sites: 46 to 45v24 Show 4 more changesShow less
    • Primary completion date: Nov 8, 2022 to Nov 21, 2022
    • Study completion date: Sep 11, 2029 to Jul 5, 2029
    • Secondary endpoints: 18 to 20
    • Eligibility criteria expanded, about 2 words
  33. Primary completion date: Jun 12, 2024 to Nov 8, 2022
    • Study sites: 47 to 46
    • Study completion date: Jun 10, 2029 to Sep 11, 2029
    v23
  34. Primary completion date: May 25, 2022 to Jun 12, 2024
    • Study sites: 46 to 47
    • Study completion date: May 23, 2027 to Jun 10, 2029
    v22
  35. Study sites: 42 to 46v21
  36. Study sites: 38 to 42v20
  37. Site details revised at 2 of 38 sitesv19
  38. Site details revised at 2 of 38 sitesv18
  39. Primary completion date: Apr 23, 2022 to May 25, 2022
    • Study completion date: Apr 21, 2027 to May 23, 2027
    • Study sites revised (38)
    v17
  40. Study sites: 36 to 38
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 19 to 18
    v16
  41. Study sites: 34 to 36
    • Primary completion date: Nov 26, 2021 to Apr 23, 2022
    • Study completion date: Nov 24, 2026 to Apr 21, 2027
    v15
  42. Study sites: 31 to 34v14
  43. Study sites: 28 to 31v13
  44. Study sites: 26 to 28v12
  • 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
441 trials monitored
See 30 trials at risk
Hemophilia
242 trials monitored
See 13 trials at risk
This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate \[ABR\] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).
Trial Details
NCT Number NCT03861273
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Hemophilia B
Related terms Hematologic Diseases, Hemophilia A, Hemophilia B
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov