Terminated/Withdrawn

Hemophilia

Bayer Identifier:

20414

ClinicalTrials.gov Identifier:

NCT03996486

EudraCT Number:

2018-004566-34

EU CT Number:

Not Available

Study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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 summary

Enrollment Goal

Trial Dates

October 2019 - July 2020

Phase

Phase 1

Could I Receive a placebo

Products

BAY1093884

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn	University of Colorado Hospital	Aurora, 80045, United States
Withdrawn	Institute of Blood Pathology and Transfusion medicine	Lviv, 79044, Ukraine
Withdrawn	City Clinical Hospital #9	Kiev, Ukraine
Withdrawn	Rush University Medical Center	Chicago, 60612, United States
Withdrawn	University of Minnesota Medical Center	Minneapolis, 55455, United States
Withdrawn	Rutgers Robert Wood Johnson Medical School	New Brunswick, 08901, United States

Primary Outcome

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

Trial design

A multicenter, non-randomized, open-label, multiple dose escalation study to evaluate the safety and tolerability of subcutaneous BAY1093884 in males with severe hemophilia

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

N/A

Assignment

Sequential Assignment

Trial Arms