Clinical trial NCT02828254: A Follow-up Evaluation Study of PRI-724-1101
Official title: A Follow-up Evaluation Study of the Safety and Efficacy of PRI-724 Administration in Patients With Cirrhosis Due to Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus-infected Cirrhosis
Lead sponsor: Komagome Hospital
Sponsor class: OTHER
Collaborators: name: Prism Pharma Co., Ltd.
name: Japan Agency for Medical Research and Development
First posted: 2016-07-11
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PRI-724 administration in patients with cirrhosis due to hepatitis C

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: Incidences of adverse events and adverse drug reactions
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
Secondary outcomes:
measure: Incidence of liver cancer
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Child-Pugh Score
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Liver biopsy (Only in applicable patients)
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Serum albumin level
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Serum fibrosis marker level(s)
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Ascitic fluid level
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
measure: Improvement rate of lower leg edema
timeFrame: 12 months after completion of the clinical trial, PRI-724-1101
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo metropolitan Komagome Hospital
Study officials:
affiliation: Komagome Metropolitan Hospital
name: Kiminori Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References: