Evidence map›Paper›PMID 32974838›Full record

Trial reportAnnals of hematology2020

Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A.

Alexander Solms, Anita Shah, Erik Berntorp, Andreas Tiede, Alfonso Iorio, Camila Linardi, Maurice Ahsman, Maria Elisa Mancuso, Tihomir Zhivkov, Toshko Lissitchkov

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Area under the curve: Comparing the value of factor VIII replacement therapies in haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2023
    Article
  9. Article
  10. Review
  11. Observational
  12. Article
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

10 authors.

Alexander SolmsClinical Pharmacometrics, Pharmaceuticals Research & Development, Bayer AG, 13353, Berlin, Germany. alexander.solms@bayer.com.ORCID https://orcid.org/0000-0002-0945-2543
Anita ShahBayer, Whippany, NJ, USA.
Erik BerntorpCentre for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden.
Andreas TiedeDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hanover, Germany.
Alfonso IorioMcMaster-Bayer Endowed Research Chair in Clinical Epidemiology of Congenital Bleeding Disorders, Department of Medicine, McMaster University, Hamilton, Canada.
Camila LinardiBayer, Whippany, NJ, USA.
Maurice AhsmanLAP&P Consultants BV, Leiden, the Netherlands.
Maria Elisa MancusoCenter for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.
Tihomir ZhivkovSpecialized Hospital for Active Treatment, Sofia, Bulgaria.
Toshko LissitchkovSpecialized Hospital for Active Treatment, Sofia, Bulgaria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC

Indexed as

Factor VIIIHemophilia AAdolescentAdultAgedCross-Over StudiesHalf-LifeHumansMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsF8 protein, humanFactor VIIIPolyethylene GlycolsRecombinant ProteinsExtended half-lifeFactor VIIIHead-to-head studyHemophilia APEGylatedPopulation pharmacokinetics

Identifiers

PMID32974838
PMCPMC7536163

What OpenQuestion holds

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Registered trials

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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.