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

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

April 21, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00141843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Genetic: ReFacto AF
Genetic: B-Domain deleted Recombinant Factor VIII
Genetic: BDDrFVIII

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00141843

Responsible Party

Study ID Numbers ^ICMJE

3082B2-310

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Wyeth

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP