NCT03196297

A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe and the United States of America (USA). 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 patients with severe haemophilia A without inhibitors.

Conditions

• Haemostasis
• Haemophilia A

Interventions

Type	Name	Description
DRUG	Concizumab	0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase
DRUG	Turoctocog alfa	Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels

Timeline

• Start date: 2017-08-16
• Primary completion: 2018-06-22
• Completion: 2020-06-03
• First posted: 2017-06-22
• Last updated: 2021-11-16
• Results posted: 2021-05-10

Locations

31 sites across 11 countries: United States, France, Germany, Italy, Japan, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study