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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02490787
Other study ID # NN7415-4159
Secondary ID 2014-003793-16U1
Status Completed
Phase Phase 1
First received July 2, 2015
Last updated July 20, 2017
Start date September 10, 2015
Est. completion date October 14, 2016

Study information

Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 14, 2016
Est. primary completion date October 14, 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand

- Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records

- Age between 18 and 64 years both inclusive, at the time of signing informed consent

- Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product or related products

- Platelet count below 50x10^9/L at screening

- Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator

- Subjects at increased risk of cardiovascular disease as judged by the investigator

Study Design


Intervention

Drug:
Concizumab
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
placebo
Administered subcutaneously (s.c., under the skin)

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site Melbourne Victoria
Austria Novo Nordisk Investigational Site Wien
Croatia Novo Nordisk Investigational Site Zagreb
France Novo Nordisk Investigational Site Bron Cedex
France Novo Nordisk Investigational Site Nantes Cedex 1
France Novo Nordisk Investigational Site Rennes
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Homburg
Israel Novo Nordisk Investigational Site Tel-Hashomer
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Kuching
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Nijmegen
Netherlands Novo Nordisk Investigational Site Utrecht
Poland Novo Nordisk Investigational Site Warszawa
Spain Novo Nordisk Investigational Site Madrid
Thailand Novo Nordisk Investigational Site Bangkok
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Ukraine Novo Nordisk Investigational Site Dnipropetrovsk
Ukraine Novo Nordisk Investigational Site Lviv
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Southampton
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Croatia,  France,  Germany,  Israel,  Malaysia,  Netherlands,  Poland,  Spain,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Secondary Trough level of concizumab Prior to the last s.c. dose administration (day 42)
Secondary Frequency of binding non-neutralizing anti-concizumab antibodies From first trial drug administration (day 1) to 11 weeks after the first trial product administration
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