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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00141843

Purpose

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.

Condition	Intervention	Phase
Hemophilia A	Genetic: ReFacto AF Genetic: B-Domain deleted Recombinant Factor VIII Genetic: BDDrFVIII	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
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.

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:

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 Measures:

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.

Estimated Enrollment:	100
Study Start Date:	July 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141843

Show 41 Study Locations

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 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

More Information

No publications provided

Study ID Numbers:	3082B2-310
Study First Received:	August 30, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00141843 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Institutional Review Board; France: Ministry of Health; Germany: Ethics Commission; Italy: Ministry of Health; Mali: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Greece: National Organization of Medicines; Turkey: Ministry of Health; Spain: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health; United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health; Switzerland: Swissmedic; Israel: Israeli Health Ministry Pharmaceutical Administration; Hungary: National Institute of Pharmacy; Croatia: Ministry of Health and Social Care; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; United Kingdom: National Health Service; Australia: Human Research Ethics Committee; New Zealand: Health Research Council; Taiwan: Department of Health

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