Completed

Phase I / IIa Clinical Trial for Patients With Hepatitis C or B Virus Derived Liver Cirrhosis by CBP / β Catenin Inhibitor PRI-724

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What is being tested

PRI-724

Drug
Who is being recruted

Blood-Borne Infections+15

+ Communicable Diseases

+ Digestive System Diseases

From 20 to 74 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: July 2018
See protocol details

Summary

Principal SponsorKiminori Kimura, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2018

Actual date on which the first participant was enrolled.

【Phase I Phase】 To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724. 【Phase IIa phase】 To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV or HBV liver cirrhosis.

Official TitlePhase I / IIa Clinical Trial for Patients With Hepatitis C or B Virus Derived Liver Cirrhosis by CBP / β Catenin Inhibitor PRI-724
NCT03620474
Principal SponsorKiminori Kimura, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsFibrosisHepatitisHepatitis BHepatitis, Viral, HumanHepatitis CInfectionsLiver CirrhosisLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsHepadnaviridae Infections

Criteria

Inclusion Criteria: * Patients with liver cirrhosis caused by HCV or HBV that satisfies the following (1) or (2) and satisfies (3) 1. Patients with serum HCV-RNA positive or HCV antibody positive 2. Patients with serum HBV-DNA positive or HBs antigen positive 3. confirmed liver cirrhosis by liver biopsy performed in the screening period patients who received diagnosis * Patients with Child-Pugh classification in A or B status * Patients who satisfy HCV cirrhosis from (1) to (3), HBV cirrhosis (4) In the case of HCV cirrhosis; 1. Patients who have not reached SVR \* with DAA therapy 2. Patients who are difficult to implement DAA therapy 3. Patients who have been over 24 weeks after achieving SVR \* with DAA therapy In case of HBV cirrhosis; 4. Patients who have been at least 24 weeks since the start of administration of Nucleotide analogue \* SVR is SVR 12 (sustained virological response at 12 weeks after the end of administration). * Patients with Performance Status 0 to 2 * Patients aged 20 years or over and under 75 when acquiring informed consent * Regarding participation in this trial (including liver biopsy), patients who obtained informed consent by their own voluntary intention Exclusion Criteria: * Patients with HCV and HBV co-infection, patients who came to cirrhosis due to causes other than HCV or HBV, or patients whose cause of cirrhosis is unknown * Patients with esophageal gastric varices determined to be treated by endoscopic examination at screening * Patients with complication or previous history of primary liver cancer (excluding those who have had more than one year of hepatocarcinoma resection / radiofrequency ablation) * Merger of malignant tumor or past patients (within 3 years before screening). However, the following diseases are excluded: treated basal cell carcinoma, treated lung intraepithelial carcinoma, treated cervical carcinoma, or control superficial (not invasive) bladder carcinoma * Patients who can not be denied HIV, HTLV-1 or syphilis * Serum creatinine value: Patients with more than 1.5 times the upper limit of the facility reference value * Patients with poor control of diabetes, hypertension or heart failure * Patients with psychiatric diseases judged to have the potential to influence the implementation of clinical trials * Patients who have severe allergy to or contrast media * Patients with HCV who have not passed the following period after treatment for HCV cirrhosis at registration. * 12 weeks after the final administration of interferon * 16 weeks after final administration of Ribavirin * 16 weeks after final administration of DAA * Patients whose dosage regimen was changed within 12 weeks prior to enrollment * Patients who have history of drug or alcohol intoxication within 5 years before acquiring informed consent or who have history of drug or alcohol abuse within the past year * Patients who participated in other clinical trials and clinical trials within 30 days prior to acquisition of consent, patients who used investigational drugs or investigational equipment * Patients who received liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who are difficult to intravenously administer * Patients whose liver biopsy is expected to be difficult to perform * Patients who are pregnant or nursing, or who are likely to become pregnant * Male patients who do not obtain consent to contraception from the time of acquiring informed consent until the end of 12 weeks after the administration of investigational drug * In addition, patients investigated by investigators or clinical trial doctors as judged unsuitable for this trial

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Dose: 140, 280, 380 mg / m 2/4 hr Administration method: 【Phase I Phase】 (Level 1) 140 mg / m 2/4 hr (Level 2) 280 mg / m 2/4 hr (Level 3) 380 mg / m 2/4 hr Twice weekly, continuous 4-hour intravenous administration (tolerance of administration time: ± 15 minutes). This is one cycle and 12 cycles (12 weeks in total) are carried out. However, in Phase I phase, single dose is administered on Day - 7 (tolerance: - 7 days). 【Phase IIa phase】 Continuous intravenous administration for 4 hours twice a week at the recommended dose determined in Phase I. This is one cycle and 12 cycles (12 weeks in total) are carried out.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Kohnodai Hospital, National Center for Global Health and Medicine

Ichikawa, JapanOpen Kohnodai Hospital, National Center for Global Health and Medicine in Google Maps
Suspended

Tokyo Metropolitan Komagome Hospital

Bunkyō-Ku, Japan
Suspended

Kyushu University Hospital

Fukuoka, Japan
Completed3 Study Centers