Evidence map›Paper›PMID 38677720›Full record

ArticleBMJ open gastroenterology2024

Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study.

Kiminori Kimura, Junko Tanuma, Masamichi Kimura, Jun Imamura, Mikio Yanase, Ichiro Ieiri, Masayuki Kurosaki, Tsunamasa Watanabe, Tomoyuki Endo, Hiroshi Yotsuyanagi and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in BMJ open gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04688034 (Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia.), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 24% 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.

NCT04688034 phase1completednot on this map

Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia. (OP-724-H101)

TypeinterventionalSponsorKiminori Kimura, MDRan2021 to 2022Enrolled5ConditionsLiver CirrhosisArmsOP-724
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. CBP/β-Catenin Signaling in Hepatocytes Plays Pivotal Roles in MMP-7-Mediated Liver Fibrosis in a Metabolic Dysfunction-Associated Steatohepatitis Mouse Model.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  2. Signaling pathways and targeted interventions for precancers.Signal transduction and targeted therapy · 2026
    Review
  3. 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

11 authors at 7 institutions in 1 country.

Kiminori KimuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan kiminori_kimura@tmhp.jp.ORCID 0000-0002-9352-4721
Junko TanumaAIDS Clinical Center, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.
Masamichi KimuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan.
Jun ImamuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan.
Mikio YanaseDepartment of Gastroenterology, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.
Ichiro IeiriDepartment of Clinical Pharmacokinetics, Division of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
Masayuki KurosakiDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
Tsunamasa WatanabeDivision of Gastroenterology and Hepatology, St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Tomoyuki EndoDepartment of Hematology, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.
Hiroshi YotsuyanagiDivision of Infectious Diseases, Advanced Clinical Research Center, Institute of Medical Science, University of Tokyo, Minato-ku, Tokyo, Japan.
Hiroyuki GatanagaAIDS Clinical Center, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.
National Center for Global Health and Medicine · JPTokyo Metropolitan Komagome Hospital · JPHokkaido University Hospital · JPKyushu University · JPMusashino Red Cross Hospital · JPSt. Marianna University School of Medicine · JPTokyo University of Science · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePatients with haemophilia and HIV who acquire hepatitis C virus (HCV) after receiving contaminated blood products can experience accelerated progression of liver fibrosis and a poor prognosis, making liver disease a prominent cause of mortality among these patients. In the current study, we aimed to evaluate the safety and tolerability of the potential antifibrotic agent OP-724-a CREB-binding protein/β-catenin inhibitor-in this patient subset.

designIn this single-centre, open-label, non-randomised, phase I trial, we sequentially enrolled patients with cirrhosis following HIV/HCV coinfection classified as Child-Pugh (CP) class A or B. Five patients received an intravenous infusion of OP-724 at doses of 140 or 280 mg/m

resultsBetween 9 February 2021 and 5 July 2022, five patients (median age: 51 years) were enrolled. All five patients completed 12 cycles of treatment. SAEs were not observed. The most common AEs were fever (60%) and gastrointestinal symptoms (diarrhoea: 20%, enterocolitis: 20%). Improvements in LSM and serum albumin levels were also observed.

conclusionIn this preliminary assessment, intravenous administration of 140 or 280 mg/m TRIAL REGISTRATION NUMBER: NCT04688034.

Indexed as

CoinfectionHemophilia AHIV InfectionsLiver CirrhosisAdultElasticity Imaging TechniquesFemaleHepatitis CHumansInfusions, IntravenousMaleMiddle AgedTreatment OutcomeHCVHEPATIC FIBROSISHIV-RELATED GASTROINTESTINAL DISEASELIVER CIRRHOSIS

Identifiers

PMID38677720
PMCPMC11057312
OpenAlexW4395697670

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.