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 Bicêtre 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
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