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Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Primary and study completion pushed from Jun 26, 2026 to Oct 26, 2026 · Site details revised at 20 of 20 sitesv21 Show 2 more changesShow less
    • Primary and study completion pushed from Jun 26, 2026 to Oct 26, 2026
    • Site details revised at 20 of 20 sites
  2. Study sites revised (20)v20 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 16 to 20 Eligibility criteria expanded, about 8 wordsv19 Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 15 to 16v18
  5. Site details revised at 3 of 15 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Re-verified, no change to tracked fieldsv16
  2. Study sites: 14 to 15v15
  3. Site details revised at 1 of 14 sitesv14
  4. Study sites: 11 to 14v13
  5. Site details revised at 3 of 11 sitesv12
  6. Study sites: 10 to 11v11
  7. Re-verified, no change to tracked fieldsv10
  8. Site details revised at 1 of 10 sitesv9
  9. Study sites: 8 to 10v8
  10. Site details revised at 1 of 8 sitesv7
  11. Study sites: 7 to 8v6
  12. Study sites: 6 to 7v5
  13. Study sites: 5 to 6v4
  14. Study sites: 1 to 5v3
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: Feb 26, 2026 to Jun 26, 2026 · Start date changed from estimate of Jan 2025 to Jan 9, 2025v2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Feb 26, 2026 to Jun 26, 2026
    • Start date changed from estimate of Jan 2025 to Jan 9, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
CSL Behring
30 trials monitored
See 2 trials at risk
Hemophilia
236 trials monitored
See 12 trials at risk
For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than \[\<\] 1%).
Trial Details
NCT Number NCT06738485
Lead Sponsor CSL Behring
Conditions Congenital Hemophilia A
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov