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NCT00092976 Clinical Trial

Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Hemophilia A Clinical Trial

Official title:
A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092976
Other study ID # 3082A2-401
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2004
Last updated December 19, 2007
Start date February 2003
Est. completion date July 2007

Study information
Verified date May 2006
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

The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Age = 6 years

- Male previously treated patients (=150 Exposure Days) with moderate or severe hemophilia A (i.e. = 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)

- Ability to adhere to the protocol requirements

Exclusion Criteria:

- Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU

- Prior participation in this study

- Any concomitant bleeding disorder other than hemophilia A

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ReFacto

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
Secondary To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
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