Brief Title
Study Evaluating ReFacto AF in Severe Hemophilia A
Official Title
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
Brief Summary
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
Study Phase
Phase 3
Study Type
Interventional
Condition
Hemophilia A
Intervention
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
Completion Date
August 2004
Primary Completion Date
August 2004
Eligibility Criteria
Inclusion Criteria: - Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory) - Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product - Age greater than or equal to 12 years - History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study - Adequate laboratory results Exclusion Criteria: - Presence of any bleeding disorder in addition to hemophilia A - Concomitant therapy with immunosuppressive drugs - Current or historical Factor VIII inhibitor - Treatment with any investigational drug or device within the past 30 days
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, MD, ,
Administrative Informations
NCT ID
NCT00037544
Organization ID
3082B1-306
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, MD, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
April 2008