Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Wyeth is now a wholly owned subsidiary of Pfizer

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hemophilia A

Interventions

ReFacto AFDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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