Brief Title
Study Evaluating Pharmacovigilance Of Refacto AF
Official Title
Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
Brief Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type
Observational
Primary Outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary Outcome
Mean Total Number of Bleeding Episodes Per Year in Participants
Condition
Hemophilia A
Intervention
ReFacto AF (Moroctocog alfa)
Study Arms / Comparison Groups
1
Description: Patients treated with Refacto AF
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
101
Start Date
July 17, 2009
Completion Date
October 19, 2016
Primary Completion Date
October 19, 2016
Eligibility Criteria
Inclusion Criteria: - Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF. Exclusion Criteria: - Patients with Hemophilia A treated with a product other than Refacto AF.
Gender
All
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
NCT00895037
Organization ID
3082B2-4420
Secondary IDs
B1831016
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2017