Evidence map›Paper›PMID 39934428›Full record

ArticleAnnals of hematology2025

A randomized, two-armed, double-blind, single-dose, cross-over, bioequivalence clinical trial to compare pharmacokinetic parameters and safety of recombinant human factor VIII with Fc fusion produced by AryoGen Pharmed Company versus Elocta

Aziz Eghbali, Peyman Eshghi, Gholamreza Toogeh, Samin Alavi, Zahra Badiei, Majid Ghanavat, Mohammadreza Bordbar, Asghar Bazrafshan, Katayoon Karimi, Minoo Ahmadinejad and 2 more

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

Article in Annals of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Aziz EghbaliAliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran.
Peyman EshghiPediatric Congenital Hematologic Disorders Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Gholamreza ToogehThrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Samin AlaviPediatric Congenital Hematologic Disorders Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Zahra BadieiHemophilia and Thalassemia Center of Mashhad (Sarvar Clinic), Mashhad University of Medical Sciences, Mashhad, Iran.
Majid GhanavatIsfahan University of Medical Sciences, Isfahan, Iran.
Mohammadreza BordbarHematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Asghar BazrafshanHemophilia Center, Dastgheib Hospital, Shiraz, Iran.
Katayoon KarimiThrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Minoo AhmadinejadBlood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.
Araz SabzvariCinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.
Hamidreza KafiMedical Department, Orchid Pharmed Company, Tehran, Iran. Kafi.H@orchidpharmed.com.ORCID https://orcid.org/0009-0008-1246-8969

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This clinical study evaluates the bioequivalence of recombinant factor VIII with Fc fusion protein (rFVIII-Fc) developed by AryoGen Pharmed Company compared to the reference product, Elocta

Indexed as

Factor VIIIHemophilia AImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsAdolescentAdultCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedTherapeutic EquivalencyYoung AdultF8 protein, humanFactor VIIIfactor VIII-Fc fusion proteinImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsArea under curveBiosimilar pharmaceuticalsCross-over studyFactor VIIIHaemophilia APharmacokinetics

Identifiers

PMID39934428
PMCPMC11971217

What OpenQuestion holds

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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.