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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01631942
Other study ID # NN7415-3986
Secondary ID 2011-005757-32U1
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 26, 2012
Est. completion date September 4, 2012

Study information

Verified date May 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. 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 NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.


Description:

The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 4, 2012
Est. primary completion date September 4, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product(s) or related products

- Thrombocyte count below the lower limit of normal range at screening

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

Study Design


Intervention

Drug:
NNC172-2021
Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation.

Locations

Country Name City State
Austria Novo Nordisk Investigational Site Wien
France Novo Nordisk Investigational Site Lyon
France Novo Nordisk Investigational Site Montpellier
Germany Novo Nordisk Investigational Site Berlin
Spain Novo Nordisk Investigational Site Madrid
United Kingdom Novo Nordisk Investigational Site Harrow

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  France,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2):

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) From first trial drug administration through trial day 35
Secondary Local tolerability After the last s.c. dose administration (trial day 15)
Secondary Thrombocyte count After the last s.c. dose administration (trial day 15)
Secondary Trough level (Ctrough) Prior to the last s.c. dose administration (trial day 15)
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