Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Drug: ReFacto AF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038935

3082B1-305

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind