An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery - Study 311

• Conditions: Male subjects with hemophilia A (FVIII:C =2% confirmed at screening), previously treated with = 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated to require FVIII infusions over a period of at least 6 days following surgery; MedDRA version: 8.1Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIII

• Registration Number: EUCTR2005-001579-37-SE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

- Male subjects with hemophilia A- FVIII:C = 2%
- Age = 12 years
- A negative FVIII inhibitor at both the local laboratory and central laboratory at screening
- A negative past medical history of a FVIII inhibitor
- Previously treated with = 150 exposure days to any Factor VIII product
- The subject will be undergoing elective major surgery that is anticipated to require FVIII infusions and daily FVIII activity monitoring over a period of at least 6 days following surgery
- ALT (SGOT) and AST (SGPT) =5.0 x ULN, and bilirubin =2mg/dL (33 µmol/L)
- Serum albumin = LLN- Serum creatinine =1.25 x ULN- Platelet count = 100,000 /µL
- Absolute CD4 count >200 µL
- PT =1.25 x ULN or INR = 1.5
- Patients receiving therapy for HIV or Hepatitis infection, must be on a stable antiviral regimen at the time of study entry
- The patient should be able to comply with the mandatory 72-hour washout period as specified in the protocol
- The patient should be able to comply with the required inpatient length of
stay including at least 2 days for BI subjects and at least 6 days for all CI
subjects
The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to inclusion criteria.
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

- A history of FVIII inhibitor (clinical or laboratory based assessment, as defined in the protocol definitions), such as recurrent low titer values. Any measured Bethesda inhibitor titer greater than or equal to 0.6 BU/mL, regardless of the laboratory normal range, or any measured Bethesda inhibitor titer greater than the upper limit of normal for the laboratory performing the assay
- Presence of a bleeding disorder in addition to hemophilia A
- Treatment with any investigational drug or device within the past 30 days, except for subjects entering from other studies of ReFacto AF
- Prior participation in this study (except for screen failures)
- Regular (e.g. daily, QOD) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain NSAIDs
- Concomitant therapy with immunosuppressive drugs (e.g., IVIG, routine systemic corticosteroids)
- Known hypersensitivity to hamster protein
- Unwilling or unable to follow the terms of the protocol
The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to exclusion criteria.

Study & Design

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