Back to resultsStudy Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReFacto
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia A focused on measuring Hemophilia A
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
Full Information
NCT ID
NCT00092976
First Posted
September 28, 2004
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00092976
Brief Title
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
Hemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ReFacto
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0019
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
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