At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 240 enrolled
Drug / intervention
rFVIIIFcdrug
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.
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A
In Brief
A Phase 3 clinical trial evaluating rFVIIIFc for Hemophilia A. Completed, enrolled 240 participants across 78 sites in 22 countries.
Detailed Summary
The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionOct 2017
TodayJul 2026
First PostedOct 19, 2011
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.7 years ago
Interventions
rFVIIIFcdrug
Administered as specified in the treatment arm.