At a glance
ClinicalIndex Comparison RecordN/ACompleted· 288 enrolled
Drug / intervention
Moroctocog alfadrug
Likely dose
Moroctocog alfa dosed individually by physician per ReFacto labeling requirements in GermanyAI-extracted
Key inclusion· 1
- ✓Confirmed diagnosis of hemophilia A
Key exclusion· 1
- ✕Any contraindications listed in the ReFacto Summary of Product Characteristics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacovigilance Evaluation Of Refacto In Usual Care Settings
Wyeth is now a wholly owned subsidiary of Pfizer·observational·Posted Sep 19, 2005·Updated Feb 11, 2011
In Brief
An observational study evaluating Moroctocog alfa for Hemophilia A. Completed, enrolled 288 participants across 26 sites in 2 countries.
Detailed Summary
The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustria, Germany
Collaborators--
Timeline
N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 1999
First PostedSep 2005
Primary CompletionJan 2010
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartJul 1, 1999
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 20.8 years ago
Interventions
Moroctocog alfadrug
Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.