drugset / Trial / NCT04085458

Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

NCT04085458

Phase 4 Completed 32 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

Timeline

Start
2019-09-23
Primary completion
2022-05-20
Completion
2022-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Damoctocog alfa pegol Protein / enzyme biologic 45 iu/kg

Indications