Hepatitis C Virus-infected Cirrhosis
Conditions
Brief summary
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
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).
Interventions
DRUGPRI-724
Sponsors
Prism Pharma Co., Ltd.
Japan Agency for Medical Research and Development
Komagome Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Having provided voluntary written consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidences of adverse events and adverse drug reactions | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each adverse events, cohort and Child-Pugh score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child-Pugh Score | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Liver biopsy (Only in applicable patients) | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Serum albumin level | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Incidence of liver cancer | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Ascitic fluid level | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Improvement rate of lower leg edema | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
| Serum fibrosis marker level(s) | 12 months after completion of the clinical trial, PRI-724-1101 | The data will be aggregated by each cohort and Child-Pugh score |
Countries
Japan
Outcome results
None listed