Phase I / IIa Clinical Trial for Patients With Hepatitis C or B Virus Derived Liver Cirrhosis by CBP / β Catenin Inhibitor PRI-724
PRI-724
Blood-Borne Infections+15
+ Communicable Diseases
+ Digestive System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Kohnodai Hospital, National Center for Global Health and Medicine
Ichikawa, JapanOpen Kohnodai Hospital, National Center for Global Health and Medicine in Google MapsTokyo Metropolitan Komagome Hospital
Bunkyō-Ku, JapanKyushu University Hospital
Fukuoka, Japan