Evidence map›Paper›PMID 31236667›Full record

Trial reportAnnals of hematology2019

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

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

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  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
  13. Article
  14. 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

10 authors at 7 institutions in 6 countries.

Anita ShahBayer, Whippany, USA. anita.shah@bayer.com.
Alexander SolmsBayer, Berlin, Germany.
Sara WiegmannBayer, Wuppertal, Germany.
Maurice AhsmanLAP&P Consultants BV, Leiden, the Netherlands.
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, Hannover, Germany.
Alfonso IorioDepartment of Health Research Methods, Evidence and Impact, and Department of Medicine, McMaster University, Hamilton, Canada.
Maria Elisa MancusoFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.
Tihomir ZhivkovSpecialized Hospital for Active Treatment, Sofia, Bulgaria.
Toshko LissitchkovSpecialized Hospital for Active Treatment, Sofia, Bulgaria.
Bayer (Germany) · DEUniversity Specialized Hospital for Active Treatment of Endocrinology · BGBayer (United States) · USFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITLund University · SEMcMaster University · CAMedizinische Hochschule Hannover · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BAY 94-9027 is an extended-half-life, recombinant factor VIII (rFVIII) product conjugated with a 60-kDa branched polyethylene glycol (PEG) molecule indicated for use in previously treated patients (aged ≥ 12 years) with hemophilia A. This randomized, open-label, two-way crossover study compared the pharmacokinetics (PK) of BAY 94-9027 and rFVIII Fc fusion protein (rFVIIIFc) in patients with hemophilia A. Patients aged 18-65 years with FVIII < 1% and ≥ 150 exposure days to FVIII were randomized to receive intravenous single-dose BAY 94-9027 60 IU/kg followed by rFVIIIFc 60 IU/kg or vice versa, with ≥ 7-day wash-out between doses. FVIII activity was measured by one-stage assay. PK parameters, including area under the curve from time 0 to the last data point (AUC

Indexed as

Factor VIIIHemophilia APolyethylene GlycolsRecombinant Fusion ProteinsAdolescentAdultAgedCross-Over StudiesHumansMaleMiddle AgedBAY 94-9027F8 protein, humanFactor VIIIPolyethylene GlycolsRecombinant Fusion ProteinsExtended half-lifeHead-to-head studyHemophilia APEGylatedPharmacokineticsPopulation pharmacokinetics

Identifiers

PMID31236667
PMCPMC6700041
OpenAlexW2949365580

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.