At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
recombinant Factor VIIIbiological
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.
Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating recombinant Factor VIII for Severe Hemophilia A. Completed, enrolled 32 participants across 11 sites in 4 countries.
Detailed Summary
This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesAustria, Bulgaria, Germany, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedMay 18, 2010
Enrollment StartJun 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.1 years ago
Interventions
recombinant Factor VIIIbiological
intravenous infusion of factor FVIII every other day.