Study Evaluating ReFacto in Hemophilia A

Wyeth

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: BDDrFVII

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038909

3082A1-302

Details and patient eligibility

About

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).

Enrollment: 103 patients

Sex: All

Volunteers: No Healthy Volunteers

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.