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NCT02490787

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

Completed Phase 1 Last updated 21 July 2017
What this trial tests

Phase 1 trial testing Concizumab in Congenital Bleeding Disorder in 24 participants. Completed in 14 October 2016.

Timeline
10 September 2015
Primary endpoint
14 October 2016
14 October 2016

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingdouble
Primary purposetreatment
Enrollment24
Start date10 September 2015
Primary completion14 October 2016
Estimated completion14 October 2016
Sites34 locations across France, Netherlands, Malaysia, Ukraine, Austria, United Kingdom, Germany, Israel

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 64, male only, with Congenital Bleeding Disorder or Haemophilia A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Molecular Revolution in the Treatment of Hemophilia.
    Butterfield JSS, Hege KM, Herzog RW, Kaczmarek R. · · 2020 · cited 76× · PMID 31843450 · DOI 10.1016/j.ymthe.2019.11.006
  2. A randomized trial of safety, pharmacokinetics and pharmacodynamics of concizumab in people with hemophilia A.
    Eichler H, Angchaisuksiri P, Kavakli K, Knoebl P, et al · · 2018 · cited 57× · PMID 30137664 · DOI 10.1111/jth.14272
  3. Novel therapies and current clinical progress in hemophilia A.
    Balkaransingh P, Young G. · · 2018 · cited 37× · PMID 29387330 · DOI 10.1177/2040620717746312
  4. Concizumab restores thrombin generation potential in patients with haemophilia: Pharmacokinetic/pharmacodynamic modelling results of concizumab phase 1/1b data.
    Eichler H, Angchaisuksiri P, Kavakli K, Knoebl P, et al · · 2019 · cited 26× · PMID 30408848 · DOI 10.1111/hae.13627
  5. Updates on Novel Non-Replacement Drugs for Hemophilia.
    Gualtierotti R, Pasca S, Ciavarella A, Arcudi S, et al · · 2022 · cited 22× · PMID 36297295 · DOI 10.3390/ph15101183
  6. Non-factor therapies for bleeding disorders: A primer for the general haematologist.
    Swan D, Mahlangu J, Thachil J. · · 2022 · cited 18× · PMID 36051064 · DOI 10.1002/jha2.442
  7. Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management.
    Mahlangu JN. · · 2021 · cited 18× · PMID 34026796 · DOI 10.3389/fmed.2021.670526
  8. Novel alternate hemostatic agents for patients with inhibitors: beyond bypass therapy.
    Ragni MV. · · 2017 · cited 6× · PMID 29222310 · DOI 10.1182/asheducation-2017.1.605

Verify or expand the search:

Other trials of Concizumab

Trials testing the same drug.

Other recruiting trials for Congenital Bleeding Disorder

Currently open trials in the same condition.

Other Novo Nordisk A/S trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02490787.

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