At a glance
ClinicalIndex Comparison RecordN/ACompleted· 58 enrolled
Drug / intervention
No interventionother
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.
Post Marketing Observational Study Of Reformulated BeneFIX
In Brief
An observational study evaluating No intervention for Hemophilia B. Completed, enrolled 58 participants across 17 sites.
Detailed Summary
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesFrance
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedFeb 2009
Primary CompletionOct 2013
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.4 years ago
Interventions
No interventionother
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician