Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

April 21, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.

The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Perth, Australia, 6000
  • Belgium
      • Leuven, Belgium, 3000
  • Finland
      • Helsinki, Finland, 00029
  • France
      • Le Kremlin Bicêtre, France, 94275
      • Rouen, France, 76031
  • Germany
      • Berlin, Germany, 10249
      • Muenster, Germany, 48143
  • Hungary
      • Budapest, Hungary, H-1135
  • Italy
      • Milano, Italy, 20122
  • Netherlands
      • Groningen, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Hamilton, New Zealand
  • Poland
      • Lodz, Poland, 95-510
      • Poznan, Poland
      • Warszawa, Poland, 00-576
      • Wroclaw, Poland
  • Spain
      • Madrid, Spain, 28046
      • Valencia, Spain, 46009
  • Sweden
      • Malmö, Sweden
      • Stockholm, Sweden, 171 76
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • California
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92123
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • East Lansing, Michigan, United States, 48823
    • Missouri
      • St. Louis, Missouri, United States, 63014
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-0019
    • New York
      • Buffalo, New York, United States, 14215
      • New Hyde Park, New York, United States, 11040
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Dayton, Ohio, United States, 45404
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84113
    • Virginia
      • Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects with severe or moderately severe hemophilia A
  • A negative past medical history of a Factor VIII inhibitor
  • Age greater than or equal to 12 years

Exclusion Criteria:

  • A history of Factor VIII inhibitors
  • Presence of a bleeding disorder in addition to hemophilia
  • Known hypersensitivity to hamster protein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.

Secondary Outcome Measures

Outcome Measure
To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Australia, New Zealand, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Sweden, Finland,MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For Poland, WVWZMED@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3082B2-310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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