At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
rFIXFcbiological
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 IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
In Brief
A Phase 3 clinical trial evaluating rFIXFc for Severe Hemophilia B. Completed, enrolled 120 participants across 49 sites in 18 countries.
Detailed Summary
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia B
CountriesAustralia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Netherlands, Poland, South Africa, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartDec 2011
Primary CompletionOct 2017
TodayJul 2026
First PostedAug 30, 2011
Enrollment StartDec 8, 2011
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.8 years ago
Interventions
rFIXFcbiological
Administered as specified in the treatment arm.