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

NCT ID: NCT00141843

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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ReFacto AF

Intervention Type GENETIC

B-Domain deleted Recombinant Factor VIII

Intervention Type GENETIC

BDDrFVIII

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Australia, New Zealand, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Sweden, Finland,[email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Hungary, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Locations

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Phoenix, Arizona, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Atlanta, Georgia, United States

Site Status

Iowa City, Iowa, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Worcester, Massachusetts, United States

Site Status

East Lansing, Michigan, United States

Site Status

St Louis, Missouri, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

Buffalo, New York, United States

Site Status

New Hyde Park, New York, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Dayton, Ohio, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Perth, , Australia

Site Status

Leuven, , Belgium

Site Status

Helsinki, , Finland

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Rouen, , France

Site Status

Berlin, , Germany

Site Status

Münster, , Germany

Site Status

Budapest, , Hungary

Site Status

Milan, , Italy

Site Status

Groningen, , Netherlands

Site Status

Auckland, , New Zealand

Site Status

Hamilton, , New Zealand

Site Status

Lodz, , Poland

Site Status

Poznan, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Madrid, , Spain

Site Status

Valencia, , Spain

Site Status

Malmo, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Countries

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United States Australia Belgium Finland France Germany Hungary Italy Netherlands New Zealand Poland Spain Sweden

Other Identifiers

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3082B2-310

Identifier Type: -

Identifier Source: org_study_id

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