Study Evaluating ReFacto in Hemophilia A

NCT ID: NCT00038909

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-09-30
• Study Completion Date: 2001-05-31

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).

Conditions

Hemophilia A

Study Design

• Primary Study Purpose: TREATMENT

Interventions

BDDrFVII

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

3082A1-302

Identifier Type: -

Identifier Source: org_study_id