Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Biological: ReFacto AF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00243659

3082B2-311

Details and patient eligibility

About

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Enrollment: 30 patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
• Previously treated with at least 150 exposure days to any Factor VIII product
• Normal hepatic and renal function tests and no other bleeding disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

A

Experimental group

Treatment:

Biological: ReFacto AF

B

Experimental group

Treatment:

Biological: ReFacto AF