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Honey-BNCT05568459

A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

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Record History

All 22 versions: 22 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 18 words
    • Primary and study completion pushed from Aug 21, 2026 to Nov 20, 2026
    • Secondary endpoints: details revised at 6 of 13 entries
    • Site details revised at 2 of 17 sites
  2. Primary and study completion pushed from May 21, 2026 to Aug 21, 2026v21
  3. Primary and study completion dates: Jan 21, 2026 to May 21, 2026v20
  4. Enrollment target: estimated 120 to confirmed 11
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 17
    • Primary and study completion dates: Nov 21, 2025 to Jan 21, 2026
    v19
  5. Primary and study completion dates: Apr 2, 2026 to Nov 21, 2025
    • Site details revised at 4 of 22 sites
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 20 to 22v17
  2. Study sites revised (20)v16
  3. Study sites: 18 to 20v15
  4. Site contacts updated at 5 of 18 sitesv14
  5. Study sites revised (18)v13
  6. Study sites: 17 to 18v12
  7. Study sites revised (17)v11
  8. Study sites: 16 to 17v10
  9. Study sites: 15 to 16v9
  10. Study sites: 14 to 15v8
  11. Study sites: 9 to 14v7
  12. Eligibility criteria expanded, about 11 wordsv6 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 8 to 9
    • Primary and study completion dates: Mar 28, 2027 to Apr 2, 2026
    • Secondary endpoints: 15 to 13
  13. Study sites: 5 to 8
    • Start date changed from estimate of Jan 19, 2024 to Jan 17, 2024
    v5
  14. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Oct 5, 2023 to Jan 19, 2024
    • Eligibility criteria revised
    • Study sites: 0 to 5
    • Primary and study completion dates: Nov 28, 2026 to Mar 28, 2027
  15. Start date: Aug 23, 2023 to Oct 5, 2023
    • Primary and study completion dates: Sep 24, 2026 to Nov 28, 2026
    v3
  16. Primary and study completion dates: Feb 11, 2026 to Sep 24, 2026
    • Start date: Feb 14, 2023 to Aug 23, 2023
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 15 entries
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Annualized bleeding rate (ABR)
Timeframe: At least 26 Weeks Up to 96 weeks

Secondary (13)

Annualized utilization (IU/kg) of FIX replacement therapy
FIX functional (coagulant) activity (FIX:C) in participants on prophylaxis FIX replacement therapy
Difference of FIX:C in participants on prophylaxis FIX replacement therapy by one-stage and chromogenic assays
Difference of FIX:C between one-stage assay and chromogenic substrate assay by laboratory in participants on prophylaxis FIX replacement therapy
Difference of FIX:C between laboratories by assay (one-stage assay and chromogenic substrate assay) in participants on prophylaxis FIX replacement therapy
Show 8 moreShow less
Incidence of adverse event (AEs)
Severity of AEs
Hemophilia Quality of Life (Haemo-Qol-A) total and individual domain scores
Hemophilia Activities List (HAL) total and individual scores
European Quality of Life 5 Dimensions 3-levels (EQ-5D-3L) score
Hemophilia Joint Health Score (HJHS) total and individual scores per joint
Annualized medically attended visit (MAV) rate for any reason
Detection of antibodies to adeno-associated virus (AAV) capsid proteins

Arms and interventions

Cohort 1

Male participants with hemophilia B on current FIX Replacement Therapy prophylaxis or a documented genotype known to produce severe hemophilia B

Other: Non-Interventional

Sites

17 sites in 4 countries

United States 9, Germany 3, United Kingdom 3, Canada 2