Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).

• Negative test for facto VIII inhibitor.

• If applicable, HIV or hepatitis treatment is stable at the time of enrollment.

• Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria:

• History of any positive test result for factor VIII inhibitor.

• Presence of any bleeding disorder in addition to Hemophilia A.

• Body weight less than 50 kg.

• History of alcoholism.

• Treatment with investigational drug or device within 30 days prior to the Screening visit.