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NCT00243659 Clinical Trial

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

Hemophilia A Clinical Trial

Official title:
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00243659
Other study ID # 3082B2-311
Secondary ID
Status Completed
Phase Phase 3
First received October 20, 2005
Last updated June 2, 2011
Start date April 2006
Est. completion date June 2008

Study information
Verified date June 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility - 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• ReFacto AF

Locations
Country Name City State
n/a

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

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Hungary,  New Zealand,  Poland,  Romania,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Patients Who Achieved Hemostatic Efficacy After Surgery Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients. 6 weeks No
Secondary Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients. 6 weeks No
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