Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia

• Status: Withdrawn
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

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

Details

• Lead Sponsor: Bayer
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulin G; Immunoglobulins; Lipoprotein-associated coagulation inhibitor; Myeloma Proteins; Paraproteins; Thromboplastin

Criteria

Inclusion Criteria:

• Participants with hemophilia A and FVIII activity <1% or hemophilia B with FIX activity <2%

• Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer < 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified)

Exclusion Criteria:

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

• History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder

• History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension

• History or at risk for thrombotic microangiopathy