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

Phase 1

Withdrawn

• Conditions: Hemophilia
• Interventions: Drug: BAY1093884

• Registration Number: NCT03996486
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22
• Study Start: 2019-10-28
• Primary Completion: 2020-05-29
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hemophilia	BAY1093884	Dose escalation starting with 200 mg of BAY1093884

Primary Outcome Measures

Name	Time	Method
Frequency of drug-related adverse events	Up to 3 months
Frequency of drug-related serious adverse events	Up to 3 months
Frequency of adverse events of special interest	Up to 3 months	Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.