Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00168051

Purpose

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.

Condition	Intervention	Phase
Hemophilia A	Drug: ReFacto Drug: Advante	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-Length Recombinant Factor VIII (FLrFVIII)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Secondary Outcome Measures:

Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.

Estimated Enrollment:	30
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168051

Locations

United States, District of Columbia

Washington, District of Columbia, United States, 20007
United States, Georgia

Atlanta, Georgia, United States, 30322
United States, Iowa

Iowa City, Iowa, United States, 52242
United States, Louisiana

New Orleans, Louisiana, United States, 70112
Belgium

Brussels, Belgium, 1200
France

Paris, France, 75747
Germany

Munster, Germany, 48143

Berlin, Germany, 10249
Italy

Milano, Italy, 20122
Netherlands

Amsterdam, Netherlands

Utrecht, Netherlands, 3584 CX
New Zealand

Christchurch, New Zealand, 8001
United Kingdom

Manchester, United Kingdom, M13 9WL

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, MedInfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Italy, descresg@wyeth.com
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For New Zealand, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.com

More Information

No publications provided

Study ID Numbers:	3082A-101711/3082A1-900
Study First Received:	September 11, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00168051 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Wyeth:

Hemophilia A

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulants
Genetic Diseases, Inborn
Coagulation Protein Disorders
Hematologic Diseases

Therapeutic Uses
Blood Coagulation Disorders
Hematologic Agents
Hemophilia A
Pharmacologic Actions
Factor VIII

ClinicalTrials.gov processed this record on November 27, 2009