Evidence map›Paper›PMID 30408848›Full record

Trial reportHaemophilia : the official journal of the World Federation of Hemophilia2019

Concizumab restores thrombin generation potential in patients with haemophilia: Pharmacokinetic/pharmacodynamic modelling results of concizumab phase 1/1b data.

Hermann Eichler, Pantep Angchaisuksiri, Kaan Kavakli, Paul Knoebl, Jerzy Windyga, Victor Jiménez-Yuste, Philip Harder Delff, Pratima Chowdary

Open access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Haemophilia : the official journal of the World Federation of Hemophilia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Management of haemophilia A with inhibitors: A regional cross-talk.Haemophilia : the official journal of the World Federation of Hemophilia · 2022
    Review
  7. Updates on Novel Non-Replacement Drugs for Hemophilia.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  8. Article
  9. Review
  10. Review
  11. Managing Severe Hemophilia A in Children: Pharmacotherapeutic Options.Pediatric health, medicine and therapeutics · 2022
    Review
  12. Article
  13. Review
  14. A Molecular Revolution in the Treatment of Hemophilia.Molecular therapy : the journal of the American Society of Gene Therapy · 2020
    Review
  15. Article
  16. Treatment Options in Hemophilia.Deutsches Arzteblatt international · 2019
    Review
  17. Article
  18. The Dilemma of Providing Advanced Hemophilia Treatments in Developing Countries - For Whom, by Whom and Where?Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 8 institutions in 8 countries.

Hermann EichlerInstitute of Clinical Hemostaseology and Transfusion Medicine, Saarland University and University Hospital, Homburg/Saar, Germany.ORCID http://orcid.org/0000-0002-1372-0619
Pantep AngchaisuksiriDivision of Hematology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Kaan KavakliDepartment of Hematology, Ege University Children's Hospital, Izmir, Turkey.ORCID http://orcid.org/0000-0002-4910-2142
Paul KnoeblClinical Division of Hematology and Hemostasis, Medical University of Vienna, Vienna, Austria.
Jerzy WindygaDepartment of Disorders of Hemostasis and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.ORCID http://orcid.org/0000-0001-7877-4784
Victor Jiménez-YusteHaematology Department, La Paz University Hospital, Madrid, Spain.
Philip Harder DelffNovo Nordisk A/S, Copenhagen, Denmark.
Pratima ChowdaryKatharine Dormandy Haemophilia Centre and Thrombosis Unit, Royal Free London NHS Foundation Trust, London, UK.ORCID http://orcid.org/0000-0002-6690-8586
Ege University · TRHospital Universitario La Paz · ESInstytut Hematologii i Transfuzjologi · PLMahidol University · THMedical University of Vienna · ATNovo Nordisk (Denmark) · DKRoyal Free London NHS Foundation Trust · GBSaarland University · DE

Funding

Novo Nordisk
6 · The paper itself

Abstract

introductionConcizumab enhances thrombin generation (TG) potential in haemophilia patients by inhibiting tissue factor pathway inhibitor (TFPI). In EXPLORER3 (phase 1b), a dose-dependent pharmacokinetic/pharmacodynamic (PK/PD) relationship was confirmed between concizumab dose, free TFPI and TG potential.

aimDetermine the association between concizumab exposure, PD markers (free TFPI; peak TG) and bleeding episodes to establish the minimum concizumab concentration for achieving sufficient efficacy.

methodsFree TFPI predictions were generated using an estimated concizumab-free TFPI exposure-response (E

resultsThe E

conclusionConcizumab phase 2 trials will target an exposure ≥100 ng/mL, with a once-daily regimen.

Indexed as

Antibodies, Monoclonal, HumanizedCoagulantsDouble-Blind MethodHalf-LifeHemophilia AHemophilia BHemorrhageHumansPlacebo EffectThrombinTreatment OutcomeAntibodies, Monoclonal, HumanizedCoagulantsconcizumabThrombinconcizumabhaemophiliamodellingpharmacodynamicspharmacokineticsphase 1

Identifiers

PMID30408848
PMCPMC7379180
OpenAlexW2899883040

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.