Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

• Status: Terminated
• Trial end date: 2019-10-15
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII; Immunoglobulin G; Immunoglobulins; Lipoprotein-associated coagulation inhibitor

Criteria

Inclusion Criteria:

• Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity <2%, with or without inhibitors (any titer) are eligible.

• Subjects with a past history of inhibitors (any inhibitor titer) are eligible.

• Age ≥18 years.

• Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.

• For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.

• For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.

Exclusion Criteria:

• History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.

• History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.

• Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).

• History of cardiac, coronary and/or arterial peripheral atherosclerotic disease

• Platelet count <100,000/μL.

• Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm^3