Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Overview
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.
Full Title of Study: “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)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: February 2003
Interventions
- Drug: ReFacto AF
Participating in This Clinical Trial
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 Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Overall Official(s)
- Medical Monitor, MD, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.