Study Evaluating ReFacto in Hemophilia A

Not Applicable

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00038909
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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

Not available

Study Timeline

• Study Start: 1994-09
• Primary Completion: 2001-05
• Study Completion: 2001-05
• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified