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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus-infected Cirrhosis
• Intervention / Treatment: Drug: PRI-724

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).

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Tokyo Metropolitan Komagome Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PRI-724 administration in patients with cirrhosis due to hepatitis C

Description

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.

Exclusion Criteria:

1. 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.
2. Patients who do not consent to practice birth control during the clinical study (including male patients).
3. Patients with serious allergy to contrast media or a history thereof.
4. 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.
5. 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.
6. Patients who participated in another clinical trial, except PRI-724-1101 trial, within 30 days at the time of providing written consent.
7. Patients who have discontinued administration of PRI-724 in Study 1101 due to death or other reasons and become lost for follow-up.
8. 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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Komagome Hospital
• Collaborators: Japan Agency for Medical Research and Development; Prism Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2014
• Primary Completion (ACTUAL): March 27, 2017
• Study Completion (ACTUAL): January 31, 2018

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Fibrosis; Hepatitis; Hepatitis C; Liver Cirrhosis
• Other Study ID Numbers: PRI-724-1102; UMIN000014891 (OTHER: UMIN (University Hospital Medical Information) CTR)