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

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

October 9, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00168051 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Number of subjects who experiece 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.

Descriptive Information

Brief Title ^ICMJE

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Official Title ^ICMJE

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)

Brief Summary

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: ReFacto
Drug: Advante

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

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, France, Germany, Italy, Netherlands, New Zealand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00168051

Responsible Party

Study ID Numbers ^ICMJE

3082A-101711/3082A1-900

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 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

Information Provided By

Wyeth

Verification Date

October 2007

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