drugset / Trial / NCT03597022

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

NCT03597022 ↗

Phase 2 Terminated 24 enrolled Bayer
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-07-24
Primary completion
2019-10-15
Completion
2019-10-15

Outcome

Outcome not reported

Stopped: “Due to thrombosis”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY1093884 Monoclonal antibody 100 mg Subcutaneous
Subject BAY1093884 Monoclonal antibody 225 mg Subcutaneous
Subject BAY1093884 Monoclonal antibody 400 mg Subcutaneous

Indications