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NCT02490787
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
Phase 1 trial testing Concizumab in Congenital Bleeding Disorder in 24 participants. Completed in 14 October 2016.
14 October 2016
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 September 2015 |
| Primary completion | 14 October 2016 |
| Estimated completion | 14 October 2016 |
| Sites | 34 locations across France, Netherlands, Malaysia, Ukraine, Austria, United Kingdom, Germany, Israel |
Drugs / interventions tested
- Concizumab (CONCIZUMAB) — full drug profile →
- placebo
Conditions studied
- Congenital Bleeding Disorder — all drugs for Congenital Bleeding Disorder →
- Haemophilia A — all drugs for Haemophilia A →
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):
-
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 -
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 -
Novel therapies and current clinical progress in hemophilia A.
Balkaransingh P, Young G. · · 2018 · cited 37× · PMID 29387330 · DOI 10.1177/2040620717746312 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02490787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Concizumab
Trials testing the same drug.
- NCT06831734 — Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo · enrolling by invitation
- NCT06285071 — Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophi · enrolling by invitation
- NCT06234813 — Targeting TFPI With Concizumab to Improve Haemostasis in Glanzmann Thrombasthenia Patients: an in Vitro Study · NA · completed
- NCT05135559 — A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors · Phase 3 · active not recruiting
- NCT04082429 — Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors · Phase 3 · active not recruiting
Other recruiting trials for Congenital Bleeding Disorder
Currently open trials in the same condition.
- NCT06574984 — Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients · recruiting
Other Novo Nordisk A/S trials
Trials by the same sponsor.
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- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02490787 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 21 July 2017
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing