safety and effectiveness of pri-724 for hepatitis c or b virus derived liver cirrhosis

Conditions: Hepatitis C; Hepatitis B; Liver Cirrhoses

Summary: to investigate the safety and efficacy of pri-724 against hcv or hbv liver cirrhosis.

【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.

Eligibility 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

Keywords: hepatitis c virus hepatitis b virus liver cirrhosis