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

Hepatitis C Virus-infected Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828254
• Other study ID #: PRI-724-1102
• Secondary ID: UMIN000014891
• Status: Completed
• Start date: December 18, 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: July 2022
• Source: Komagome Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 31, 2018
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatitis C Virus-infected Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• PRI-724

Locations

Country	Name	City	State
Japan	Tokyo metropolitan Komagome Hospital	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Komagome Hospital	Japan Agency for Medical Research and Development, Prism Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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