Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
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.
1 other identifier
interventional
100
13 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2005
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedApril 22, 2008
April 1, 2008
1.3 years
August 30, 2005
April 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Sacramento, California, 95817, United States
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San Diego, California, 92123, United States
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Aurora, Colorado, 80045, United States
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Atlanta, Georgia, 30322, United States
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Iowa City, Iowa, 52242, United States
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New Orleans, Louisiana, 70112, United States
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Worcester, Massachusetts, 01605, United States
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East Lansing, Michigan, 48823, United States
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St Louis, Missouri, 63014, United States
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New Brunswick, New Jersey, 08903-0019, United States
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Buffalo, New York, 14215, United States
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New Hyde Park, New York, 11040, United States
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Chapel Hill, North Carolina, 27599, United States
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Dayton, Ohio, 45404, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, 37232, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84113, United States
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Charlottesville, Virginia, 22908, United States
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Perth, 6000, Australia
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Leuven, 3000, Belgium
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Helsinki, 00029, Finland
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Le Kremlin-Bicêtre, 94275, France
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Rouen, 76031, France
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Berlin, 10249, Germany
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Münster, 48143, Germany
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Budapest, H-1135, Hungary
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Milan, 20122, Italy
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Groningen, Netherlands
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Auckland, New Zealand
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Hamilton, New Zealand
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Lodz, 95-510, Poland
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Poznan, Poland
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Warsaw, 00-576, Poland
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Wroclaw, Poland
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Madrid, 28046, Spain
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Valencia, 46009, Spain
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Malmo, Sweden
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Stockholm, 171 76, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, MedInfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, descresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Australia, New Zealand, medinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Netherlands, trials-NL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Sweden, Finland,MedInfoNord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Hungary, WPBUMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Poland, WVWZMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Belgium, trials-BEL@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
July 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
April 22, 2008
Record last verified: 2008-04