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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

Page last updated: August 23, 2015

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