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OpenTrials
Completed

NCT Number: NCT02490787

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concizumab

Drug

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

Placebo

Drug

Administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Number of adverse events (AEs)

    Time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary outcomes

  1. Trough level of concizumab

    Time frame: Prior to the last s.c. dose administration (day 42)

  2. Frequency of binding non-neutralizing anti-concizumab antibodies

    Time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2015
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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