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

Fecha de inicio: 24 de julio de 2018

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