Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

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Overview

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hemophilia A

Interventions

ReFactoDRUG

AdvanteDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Severe hemophilia A * Previously treated patients with at least 150 exposure days to any Factor VIII product Exclusion Criteria: * Hypersensitivity to any recombinant Factor VIII product * History of or current Factor VIII inhibitor * Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study

Locations (13)

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Iowa City, Iowa, United States

Unnamed facility

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Secondary Outcomes

Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.

Data from ClinicalTrials.gov

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