26
Participants
Start Date
August 10, 2017
Primary Completion Date
September 19, 2018
Study Completion Date
January 31, 2020
Concizumab
A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase
Eptacog alfa
A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms
Novo Nordisk Investigational Site, Vienna
Novo Nordisk Investigational Site, Århus N
Novo Nordisk Investigational Site, Georgetown, Penang
Novo Nordisk Investigational Site, Milan
Novo Nordisk Investigational Site, Madrid
Novo Nordisk Investigational Site, Seville
Novo Nordisk Investigational Site, Indianapolis
Novo Nordisk Investigational Site, Florence
Novo Nordisk Investigational Site, Iowa City
Novo Nordisk Investigational Site, Tel Litwinsky
Novo Nordisk Investigational Site, Lviv
Novo Nordisk Investigational Site, Kota Kinabalu
Novo Nordisk Investigational Site, Los Angeles
Novo Nordisk Investigational Site, Toronto
Novo Nordisk Investigational Site, Zagreb
Novo Nordisk Investigational Site, Athens
Novo Nordisk Investigational Site, Aichi
Novo Nordisk Investigational Site, Nara
Novo Nordisk Investigational Site, Tokyo
Novo Nordisk Investigational Site, Solna
Novo Nordisk Investigational Site, London
Novo Nordisk Investigational Site, Sheffield
Lead Sponsor
Novo Nordisk A/S
INDUSTRY