drugset / Trial / NCT03196284

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

NCT03196284

Phase 2 Completed 26 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

Timeline

Start
2017-08-10
Primary completion
2018-09-19
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Concizumab Monoclonal antibody 0.15 mg/kg Subcutaneous
Subject Concizumab Monoclonal antibody 0.2 mg/kg Subcutaneous
Subject Concizumab Monoclonal antibody 0.25 mg/kg Subcutaneous
Background eptacog alfa (activated) Protein / enzyme biologic 90 ug/kg