Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

NCT ID: NCT00168051

Last Updated: 2018-09-25

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-11-30

Brief Summary

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The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

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

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ReFacto

Intervention Type DRUG

Advante

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A
* Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria

* Hypersensitivity to any recombinant Factor VIII product
* History of or current Factor VIII inhibitor
* Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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

Responsible Party

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Responsibility Role SPONSOR

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 Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For New Zealand, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For UK, [email protected]

Locations

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Washington D.C., District of Columbia, United States

Site Status

Atlanta, Georgia, United States

Site Status

Iowa City, Iowa, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Brussels, , Belgium

Site Status

Paris, , France

Site Status

Berlin, , Germany

Site Status

Münster, , Germany

Site Status

Milan, , Italy

Site Status

Amsterdam, , Netherlands

Site Status

Utrecht, , Netherlands

Site Status

Christchurch, , New Zealand

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States Belgium France Germany Italy Netherlands New Zealand United Kingdom

Other Identifiers

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3082A-101711

Identifier Type: -

Identifier Source: org_study_id

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