Study Evaluating ReFacto in Hemophilia A - Tabular View

Tracking Information

First Received Date ^ICMJE

June 5, 2002

Last Updated Date

May 17, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00038909 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating ReFacto in Hemophilia A

Official Title ^ICMJE

Factor VIII Mutation Testing Program in Previously Untreated Patients (PUPs) With Hemophilia A Participating in ReFacto® Study

Brief Summary

To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: BDDrFVII

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:

Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.
The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.
A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

Exclusion Criteria:

Any condition which, in the investigator's opinion, places the patient at undue risk.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00038909

Responsible Party

Study ID Numbers ^ICMJE

3082A1-302

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

May 2006

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