Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Wyeth is now a wholly owned subsidiary of Pfizer30 enrolled

Overview

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

ReFacto AFBIOLOGICAL

Eligibility

Sex: MALEMin age: 12 Years

Medical Language ↔ Plain English

* Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor. * Previously treated with at least 150 exposure days to any Factor VIII product * Normal hepatic and renal function tests and no other bleeding disorder

Locations (17)

Unnamed facility

La Jolla, California, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Number of Patients Who Achieved Hemostatic Efficacy After Surgery

Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

Time frame: 6 weeks

Secondary Outcomes

Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge

Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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