Evidence map›Paper›PMID 35605429›Full record

ArticleEBioMedicine2022

Safety, tolerability, and anti-fibrotic efficacy of the CBP/β-catenin inhibitor PRI-724 in patients with hepatitis C and B virus-induced liver cirrhosis: An investigator-initiated, open-label, non-randomised, multicentre, phase 1/2a study.

Kiminori Kimura, Tatsuya Kanto, Shinji Shimoda, Kenichi Harada, Masamichi Kimura, Koji Nishikawa, Jun Imamura, Eiichi Ogawa, Masanao Saio, Yoshihiro Ikura and 7 more

Open access · goldAbstract readClinical Trial, Phase IControlled Clinical TrialMulticenter Study
In one paragraph

Article in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
7.2field-weighted citation impact, top 2% 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

41 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. 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
  7. Review
  8. Review
  9. Article
  10. Signaling pathways and targeted interventions for precancers.Signal transduction and targeted therapy · 2026
    Review
  11. Review
  12. The intersection of liver cirrhosis and pulmonary fibrosis.Journal of translational medicine · 2025
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Targeting Fibrosis: From Molecular Mechanisms to Advanced Therapies.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Review
  19. Review
  20. 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

17 authors at 10 institutions in 1 country.

Kiminori KimuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan. Electronic address: kiminori_kimura@tmhp.jp.
Tatsuya KantoThe Research Center for Hepatitis and Immunology, Gastroenterology Hepatology, Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan.
Shinji ShimodaDepartment of Internal Medicine, Karatsu Red Cross Hospital, Saga, Japan.
Kenichi HaradaDepartment of Human Pathology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
Masamichi KimuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Koji NishikawaDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Jun ImamuraDepartment of Hepatology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Eiichi OgawaDepartment of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
Masanao SaioDepartment of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Gunma, Japan.
Yoshihiro IkuraDepartment of Pathology, Takatsuki General Hospital, Osaka, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Kazuaki InoueDepartment of Gastroenterology, International University of Health and Welfare, Narita Hospital, Chiba, Japan.
Tetsuya IshikawaDepartment of Integrated Health Sciences, Nagoya University Graduate School of Medicine, Aichi, Japan.
Ichiro IeiriDepartment of Clinical Pharmacokinetics, Division of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
Junji KishimotoDepartment of Clinical Research Promotion, Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Koji TodakaDepartment of Clinical Research Promotion, Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Terumi KamisawaDepartment of Gastroenterology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Tokyo Metropolitan Komagome Hospital · JPKyushu University Hospital · JPGunma University · JPInternational University of Health and Welfare · JPKanazawa University · JPKyushu University · JPNagoya University · JPNational Center for Global Health and Medicine · JPTakamatsu Red Cross Hospital · JPTakatsuki General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe conducted an exploratory study to assess the safety tolerability, and anti-fibrotic effects of PRI-724, a CBP/β-catenin inhibitor, in patients with hepatitis C virus (HCV)- and hepatitis B virus (HBV)-induced cirrhosis.

methodsThis multicentre, open-label, non-randomised, non-placebo-controlled phase 1/2a trial was conducted at three hospitals in Japan. Between July 27, 2018, and July 13, 2021, we enrolled patients with HCV- and HBV-induced cirrhosis classified as Child-Pugh (CP) class A or B. In phase 1, 15 patients received intravenous infusions of PRI-724 at escalating doses of 140, 280, and 380 mg/m

findingsThree patients from phase 1 who received the recommended PRI-724 dose were evaluated to obtain efficacy and safety data in phase 2a. Serious adverse events occurred in three patients, one of which was possibly related to PRI-724. The most common adverse events were diarrhoea and nausea. PRI-724 did not decrease hepatic fibrosis with any statistical significance, either by ordinal scoring or measurement of collagen proportionate area at 12 weeks; however, we observed statistically significant improvements in liver stiffness, Model for End-stage Liver Disease score, and serum albumin level.

interpretationIntravenous administration of 280 mg/m

fundingAMED, Ohara Pharmaceutical.

Indexed as

End Stage Liver DiseaseHepatitis CHepatitis C, ChronicHerpesvirus 1, CercopithecineAntiviral Agentsbeta CateninBridged Bicyclo Compounds, HeterocyclicHepacivirusHumansLiver CirrhosisPyrimidinonesSeverity of Illness IndexTreatment OutcomeAntiviral Agentsbeta CateninBridged Bicyclo Compounds, HeterocyclicICG 001PyrimidinonesAnti-fibrotic drugHBVHCVLiver cirrhosisPRI-724

Identifiers

PMID35605429
PMCPMC9126795
OpenAlexW4280573773

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.