Brief Title
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Official Title
A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
Brief Summary
The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.
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
February 2003
Primary Completion Date
February 2003
Eligibility Criteria
Inclusion Criteria: - Severe hemophilia A (FVIII:C < 1% at local laboratory) - Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product - Age greater than or equal to 12 years\ Exclusion Criteria: - The presence of any bleeding disorder in addition to hemophilia A - Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use) - History of detectable factor VIII inhibitor
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, MD, ,
Administrative Informations
NCT ID
NCT00038935
Organization ID
3082B1-305
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