A Follow-up Evaluation Study of PRI-724-1101

Study Overview
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Brief Summary
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The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.

Detailed Description
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This is a single-center, nonintervention, open-label, observational study in subjects who received the study drug (identification code: PRI-724) in Study 1101 to follow up the safety and disease condition of cirrhosis after administration for 12 months. In Study 1101, one cycle consisted of 2 weeks with one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. Treatment with a total of six cycles (duration of treatment, 12 weeks) was performed. In this study, the subjects in each cohort in Study 1101 (PRI-724 dose: Cohort 1, 10 mg/m2/day; Cohort 2, 40 mg/m2/day; Cohort 3, 160 mg/m2/day) were followed up and observed for 12 months after administration. In Study 1101, target number of subjects was 6 subjects in each cohort, a total of 18 subjects. However, the number of registered subjects was 7 subjects in Cohort 1, 7 subjects in Cohort 2, and 2 subjects in Cohort 3, a total of 16 subjects. Safety analysis set was 6 subjects, 6 subjects, and 2 subjects, respectively, a total of 14 subjects. Target number of the subjects in this study was the same as that in Study 1101; however, of the subjects in Study 1101, 5 subjects in Cohort 1 and 3 subjects in Cohort 2 consented to participate in this study (Study 1102).

Official Title
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A Follow-up Evaluation Study of the Safety and Efficacy of PRI-724 Administration in Patients With Cirrhosis Due to Hepatitis C

Conditions
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Hepatitis C Virus-infected Cirrhosis

Intervention / Treatment
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* Drug: PRI-724


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having been administered PRI-724 in Study 1101 after being confirmed to meet the inclusion criteria and not to meet the exclusion criteria and consenting to participate in the study. Having provided voluntary written consent for participation in this study. Exclusion Criteria: Patients who are pregnant or may be pregnant, or who desire to become pregnant or may be pregnant during the clinical study [excluding patients who have undergone a sterilization procedure or postmenopausal patients (if amenorrhea without medical reasons continues more than 12 months), patients who are nursing. Patients who do not consent to practice birth control during the clinical study (including male patients). Patients with serious allergy to contrast media or a history thereof. Patients with a history of drug or alcohol addiction within five years at the time of providing written consent or a history of drug or alcohol abuse within the past one year. Patients contraindicated for liver biopsy. However, this criterion will not apply to a patient who has turned out to be contraindicated for liver biopsy after having been administered PRI-724 in Study 1101. Patients who participated in another clinical trial, except PRI-724-1101 trial, within 30 days at the time of providing written consent. Patients who have discontinued administration of PRI-724 in Study 1101 due to death or other reasons and become lost for follow-up. Other, at the point when Study 1101 has been completed (or discontinued), patients who are judged inappropriate for inclusion in the study by the investigator for such reasons as the presence of serious pathological condition.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRI-724|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidences of adverse events and adverse drug reactions | The data will be aggregated by each adverse events, cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of liver cancer | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Child-Pugh Score | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Liver biopsy (Only in applicable patients) | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Serum albumin level | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Serum fibrosis marker level(s) | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Ascitic fluid level | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 | 
| Improvement rate of lower leg edema | The data will be aggregated by each cohort and Child-Pugh score | 12 months after completion of the clinical trial, PRI-724-1101 |