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

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