Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: ReFacto (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Los Angeles, California 90007, United States
New Brunswick, New Jersey 08903-0019, United States
Cincinnati, Ohio 45229, United States
Hershey, Pennsylvania 17033, United States
Additional Information
Starting date: February 2003
Last updated: December 19, 2007
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