Brief Title
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
Official Title
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary Outcome
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.
Condition
Hemophilia A
Intervention
ReFacto
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2005
Completion Date
November 2005
Primary Completion Date
November 2005
Eligibility Criteria
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
Gender
Male
Ages
18 Years - 64 Years
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00168051
Organization ID
3082A-101711
Responsible Party
Sponsor
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
February 2013