At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1 enrolled
Drug / intervention
Factor IX recoverybiological
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.
Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 9, 2008·Updated Jun 8, 2011
In Brief
A Phase 4 clinical trial evaluating Factor IX recovery for Hemophilia B. Completed, enrolled 1 participant across 8 sites.
Detailed Summary
The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedSep 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedSep 9, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.8 years ago
Interventions
Factor IX recoverybiological