Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT02490787

Run by

Novo Nordisk A/S

People needed

24

Starts

2015-09-10

Expected to finish

2016-10-14

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Torrance, California, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — New York, New York, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Milwaukee, Wisconsin, United States
• Novo Nordisk Investigational Site — Camperdown, New South Wales, Australia
• Novo Nordisk Investigational Site — Melbourne, Victoria, Australia
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Zagreb, Croatia
• Novo Nordisk Investigational Site — Bron, France
• Novo Nordisk Investigational Site — Nantes, France
• Novo Nordisk Investigational Site — Rennes, France
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Duisburg, Germany
• Novo Nordisk Investigational Site — Homburg, Germany
• Novo Nordisk Investigational Site — Tel Litwinsky, Israel
• Novo Nordisk Investigational Site — Kuala Lumpur, Malaysia
• Novo Nordisk Investigational Site — Kuching, Malaysia
• Novo Nordisk Investigational Site — Amsterdam, Netherlands
• Novo Nordisk Investigational Site — Nijmegen, Netherlands
• Novo Nordisk Investigational Site — Utrecht, Netherlands
• Novo Nordisk Investigational Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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