At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 enrolled
Drug / intervention
Human-cl rhFVIIIbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Open-label, Multicenter Phase 3b Study to Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A
In Brief
A Phase 3 clinical trial evaluating Human-cl rhFVIII for Severe Haemophilia A. Completed, enrolled 66 participants across 20 sites in 8 countries.
Detailed Summary
To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Haemophilia A
CountriesAustria, Bulgaria, Germany, Hungary, Poland, Romania, Slovakia, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartAug 2013
Primary CompletionJan 2015
TodayJul 2026
First PostedMay 29, 2013
Enrollment StartAug 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.1 years ago
Interventions
Human-cl rhFVIIIbiological
Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.