Study Evaluating ReFacto AF in Severe Hemophilia A
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
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
12 Years - N/A
Accepts Healthy Volunteers
Medical Monitor, MD, ,
Wyeth is now a wholly owned subsidiary of Pfizer
Medical Monitor, MD, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer