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

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 16, 2017

Primary Completion Date

June 22, 2018

Study Completion Date

June 3, 2020

Conditions
HaemostasisHaemophilia A
Interventions
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

Trial Locations (31)

10400

Novo Nordisk Investigational Site, Bangkok

14033

Novo Nordisk Investigational Site, Caen

20124

Novo Nordisk Investigational Site, Milan

22030

Novo Nordisk Investigational Site, Edirne

28046

Novo Nordisk Investigational Site, Madrid

29010

Novo Nordisk Investigational Site, Málaga

29609

Novo Nordisk Investigational Site, Brest

34098

Novo Nordisk Investigational Site, Istanbul

35100

Novo Nordisk Investigational Site, Bornova-IZMIR

37232

Novo Nordisk Investigational Site, Nashville

44093

Novo Nordisk Investigational Site, Nantes

46026

Novo Nordisk Investigational Site, Valencia

46260

Novo Nordisk Investigational Site, Indianapolis

53127

Novo Nordisk Investigational Site, Bonn

66421

Novo Nordisk Investigational Site, Homburg

73104

Novo Nordisk Investigational Site, Oklahoma City

79044

Novo Nordisk Investigational Site, Lviv

84113

Novo Nordisk Investigational Site, Salt Lake City

90027

Novo Nordisk Investigational Site, Los Angeles

00168

Novo Nordisk Investigational Site, Rome

466-8560

Novo Nordisk Investigational Site, Aichi

634-8522

Novo Nordisk Investigational Site, Nara

160-0023

Novo Nordisk Investigational Site, Tokyo

167-0035

Novo Nordisk Investigational Site, Tokyo

205 02

Novo Nordisk Investigational Site, Malmo

171 64

Novo Nordisk Investigational Site, Solna

06100

Novo Nordisk Investigational Site, Ankara

BT9 7AB

Novo Nordisk Investigational Site, Belfast

CB2 0QQ

Novo Nordisk Investigational Site, Cambridge

NW3 2QG

Novo Nordisk Investigational Site, London

SE1 7EH

Novo Nordisk Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY