A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings

• Conditions: Severe haemophilia A (FVIII:C <1%) in male patients =12 years of age with a treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products and transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products; MedDRA version: 9.1Level: LLTClassification code 10018937Term: Haemophilia A

• Registration Number: EUCTR2008-007997-39-HU
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

1. Male patients =12 years of age with severe hemophilia A (FVIII:C <1%).
2. Treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products.
3. Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
4. Serum albumin = the lower limit of normal (LLN).
5. Platelet count =100,000/µL.
6. Prothrombin time (PT) =1.25 × ULN, or international normalized ratio (INR) =1.5
7. Documented HIV-positive patients must have CD4 count >200/µL and HIV viral load <200 particles/µL confirmed within 6 months prior to enrollment.

Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Presence of any bleeding disorder in addition to hemophilia A.
2. A positive FVIII inhibitor by the local laboratory at screening and confirmed by a central laboratory Bethesda inhibitor titer = 0.6 BU/mL by Nijmegen modification of the Bethesda assay.
3. Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
4. Prior exposure to moroctocog alfa (AF-CC).
5. Treatment with any investigational agent or device within 30 days before the Enrollment visit.
6. Known hypersensitivity to hamster protein.
7. Any condition(s) that compromises the patient’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; inability to properly store study drug; expectation of poor compliance in study-related documentation).
8. Unwilling or unable to follow the terms of the protocol.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the safety of ReFacto AF. ;Secondary Objective: The secondary objective is to evaluate the efficacy of ReFacto AF.<br>;Primary end point(s): The primary end point is the development of clinically significant FVIII inhibitors. Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (= 0.6 BU using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 4-6 week interval) and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection:<br>the need for the subject to administer alternative hemostatic products in order to achieve sufficient efficacy, or =2 adverse event reports of decreased drug effect (or other AE indicating a decrease in the efficacy of the test article)<br>