At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 enrolled
Drug / intervention
BeneFIXdrug
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.
Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
In Brief
An observational study evaluating BeneFIX for Hemophilia B. Completed, enrolled 80 participants across 21 sites in 2 countries.
Detailed Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustria, Germany
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJul 2008
Primary CompletionOct 2016
TodayJul 2026
First PostedJul 14, 2008
Enrollment StartJan 1, 2008
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 18.0 years ago
Interventions
BeneFIXdrug
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.