A Single Dose, Randomized, 2-Period Crossover Study in Patients with Hemophilia A to Evaluate the Pharmacokinetics of Refacto(B-domain deleted recombinant human factor VIII (BDDrFVIII) and Advate (a full-length recombinant factor VIII (FLrFVIII) - Refacto/Advate PK switch

• Conditions: Hemophilia A

• Registration Number: EUCTR2004-003727-12-GB
• Lead Sponsor: Wyeth Pharmaceuticals, Global Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-31
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Documented history of severe hemophilia A (FVIII:C =1%)·
Previously treated patients (PTP) with at least 150 exposure days to any factor VIII product(s)
Male aged =18 years and less than 65 years
ALT and AST =5 x ULN, and bilirubin =2mg/dL
Serum creatinine =1.25 x ULN
Platelet count >100,000/µL
Absolute CD4 count =200/mL
Prothrombin time =1.25 x ULN
Serum albumin = LLN
Signed and dated informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known hypersensitivity to any recombinant factor VIII product or murine/hamster allergen
History of or current FVIII inhibitor, defined as = 0.6 BU or >ULN as defined at the local lab (whichever is lower).

Surgery within 30 days prior to Period 1, Day 1 or surgery planned during the study
The occurrence of a bleeding episode requiring FVIII replacement therapy within 3 days prior to Period 1, Day 1 (screening failure)
Factor VIII treatment within 3 days (72 hours) prior to Period 1, Day 1 (screening failure) or Period 2, Day 1.
Treatment with any investigational drug or device within the past 30 days with the exception of ReFacto, ReFacto AF or Advate.
Patients who are currently on Highly Active Anti-Retroviral Therapy (HAART) are excluded.
Unwillingness to agree to the washout period or other terms of the protocol
The presence of any condition that, in the investigator’s opinion, makes participation in the study not advisable (eg, frequent bleeding episodes that preclude a subject from abiding by the 3-day washout, poor venous access resulting in the inability to provide adequate pharmacokinetic sampling)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified