At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
rFVIIIFcbiological
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.
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With Severe Hemophilia A
In Brief
A Phase 1 clinical trial evaluating rFVIIIFc for Severe Hemophilia A. Completed, enrolled 19 participants across 8 sites in 3 countries.
Detailed Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesAustralia, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedMar 2014
Primary CompletionOct 2014
Study CompletionMay 2015
TodayJul 2026
First PostedMar 11, 2014
Enrollment StartMar 1, 2014
Primary CompletionOct 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.3 years ago
Interventions
rFVIIIFcbiological
Administered as specified in the treatment arm.