Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Wyeth

Status and phase: Withdrawn; Phase 4

Conditions: Hemophilia A

Treatments: Drug: Advante; Drug: ReFacto

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168051

3082A-101711

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind