Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiminori Kimura, MD; Komagome Hospital
• Collaborators: Japan Agency for Medical Research and Development; Kyushu University; National Center for Global Health and Medicine, Japan; Ohara Pharmaceutical Co., Ltd.; PRISM BioLab Co.,Ltd.; Prism Pharma Co., Ltd.

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