Study Evaluating ReFacto in Hemophilia A

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038909

Enrollment

103

Registered

2002-06-07

Start date

1994-09-30

Completion date

2001-05-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

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).

Interventions

DRUGBDDrFVII

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026