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

Bayer

Status and phase: Withdrawn; Phase 1

Conditions: Hemophilia

Treatments: Drug: BAY1093884

Study type: Interventional

Funder types: Industry

Identifiers

NCT03996486

20414

2018-004566-34 (EudraCT Number)

Details and patient eligibility

About

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

Full description

The primary objective is to assess the safety of multiple doses of BAY1093884.

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Hemophilia

Experimental group

Description:

Dose escalation starting with 200 mg of BAY1093884

Treatment:

Drug: BAY1093884