Study Evaluating ReFacto AF in Severe Hemophilia A - Tabular View

Tracking Information

First Received Date ^ICMJE

May 17, 2002

Last Updated Date

April 18, 2008

Start Date ^ICMJE

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00037544 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating ReFacto AF in Severe Hemophilia A

Official Title ^ICMJE

An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

Brief Summary

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: ReFacto AF

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

August 2004

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
Age greater than or equal to 12 years
History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
Adequate laboratory results

Exclusion Criteria:

Presence of any bleeding disorder in addition to hemophilia A
Concomitant therapy with immunosuppressive drugs
Current or historical Factor VIII inhibitor
Treatment with any investigational drug or device within the past 30 days

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00037544

Responsible Party

Study ID Numbers ^ICMJE

3082B1-306

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

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