Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: ReFacto AF (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
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.
Clinical Details
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)
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Last updated: April 18, 2008
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