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

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: ReFacto AF (Genetic); B-Domain deleted Recombinant Factor VIII (Genetic); BDDrFVIII (Genetic)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Germany, MedInfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Australia, New Zealand, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Sweden, Finland,MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Hungary, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WVWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com

Summary

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.

Clinical Details

Official title: 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.

Study design: Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

PERTH 6000, Australia

Leuven 3000, Belgium

Helsinki 00029, Finland

Le Kremlin BicĂȘtre 94275, France

Rouen 76031, France

Muenster 48143, Germany

Berlin 10249, Germany

Budapest H-1135, Hungary

Milano 20122, Italy

Groningen, Netherlands

Auckland, New Zealand

Hamilton, New Zealand

Lodz 95-510, Poland

Poznan, Poland

Wroclaw, Poland

Warszawa 00-576, Poland

Valencia 46009, Spain

Madrid 28046, Spain

Malmö, Sweden

Stockholm 171 76, Sweden

Phoenix, Arizona 85016, United States

Sacramento, California 95817, United States

San Diego, California 92123, United States

Aurora, Colorado 80045, United States

Atlanta, Georgia 30322, United States

Iowa City, Iowa 52242, United States

New Orleans, Louisiana 70112, United States

Worcester, Massachusetts 01605, United States

East Lansing, Michigan 48823, United States

St. Louis, Missouri 63014, United States

New Brunswick, New Jersey 08903-0019, United States

Buffalo, New York 14215, United States

New Hyde Park, New York 11040, United States

Chapel Hill, North Carolina 27599, United States

Dayton, Ohio 45404, United States

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee 37232, United States

Houston, Texas 77030, United States

Salt Lake City, Utah 84113, United States

Charlottesville, Virginia 22908, United States

Additional Information

Starting date: July 2005
Ending date: November 2006
Last updated: April 21, 2008

Page last updated: June 20, 2008

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