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NCT00038909 Clinical Trial

Study Evaluating ReFacto in Hemophilia A

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038909
Other study ID # 3082A1-302
Secondary ID
Status Completed
Phase N/A
First received June 5, 2002
Last updated February 7, 2013
Start date September 1994
Est. completion date May 2001

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date May 2001
Est. primary completion date May 2001
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BDDrFVII

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
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