Brief Title
Study Evaluating Refacto For Pharmacovigilance
Official Title
Pharmacovigilance Evaluation Of Refacto In Usual Care Settings
Brief 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.
Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type
Observational
Primary Outcome
Mean Number of Bleeding Episodes Per Patient Year
Secondary Outcome
Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Condition
Hemophilia A
Intervention
Moroctocog alfa
Study Arms / Comparison Groups
A
Description: Patients with Hemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
288
Start Date
July 1999
Completion Date
January 2010
Primary Completion Date
January 2010
Eligibility Criteria
Inclusion Criteria: - Proven diagnosis of Hemophilia A Exclusion Criteria: - Contraindications according to Summary of Product Characteristics
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00195442
Organization ID
3082A-100690
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
February 2011