Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Wyeth is now a wholly owned subsidiary of Pfizer15 enrolled

Overview

The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

ReFactoDRUG

Eligibility

Sex: MALEMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 6 years * Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis) * Ability to adhere to the protocol requirements Exclusion Criteria: * Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as \> 0.6 BU * Prior participation in this study * Any concomitant bleeding disorder other than hemophilia A

Locations (4)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

New Brunswick, New Jersey, United States

Unnamed facility

Cincinnati, Ohio, United States

Unnamed facility

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Secondary Outcomes

To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory

Data from ClinicalTrials.gov

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