PF-06741086 Multiple Dose Study in Severe Hemophilia

A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.

Inclusion Criteria:

• Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients with inhibitors to Factor VIII or Factor IX
• Episodic (on-demand) treatment regimen prior to screening
• At least 6 acute bleeding episodes during the 6-month period prior to screening

Exclusion Criteria:

• Known coronary artery, thrombotic, or ischemic disease
• Currently receiving treatment for acute bleeding episodes with APCC and cannot substitute treatment with rFVIIa