Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Phase 4

Withdrawn

• Conditions: Hemophilia A

• Registration Number: NCT00168051
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-02
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Severe hemophilia A
• Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria

• Hypersensitivity to any recombinant Factor VIII product
• History of or current Factor VIII inhibitor
• Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Secondary Outcome Measures

Name	Time	Method
Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.