An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy

An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy - An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014891

Enrollment

Registered

2014-08-20

Start date

2014-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C virus-induced cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who were eligible to 1101-study criteria and received PRI-724 treatment with written informed consent signed and dated. (2) Having provided voluntary written consent for participation in this study.

Exclusion criteria

Exclusion criteria: (1)Female patients who are pregnant or suspected to be pregnant. (2) Male patients who do not consent to using reliable contraception methods for 12 weeks after the end of infusion of PRI-724 in 1101 study. (3)Patients contraindicated for liver biopsy. Unless the patients were found to be contraindicated for liver biopsy after receiving PRI-724 in 1101 study. (4) Patients who were enrolled in other clinical study other than 1101-study within 30 days prior the consent. (5) 1101-study termination with follow-up failure due to pass-away or other reasons. (6) Patients judged by investigators ineligible due to seriousness of patients condition.

Design outcomes

Primary

Measure	Time frame
Adverse events and adverse drug reactions (including subjective symptoms and abnormal laboratory values)	—

Secondary

Measure	Time frame
(1)Incidence rate of liver cancer (2)Child-Pugh Score (3)Liver biopsy (4)Serum albumin level (5)Serum fibrosis marker level(s) (6)Ascitic fluid level (7)Improvement rate of lower leg edema	—

Countries

Japan

Contacts

Public ContactKiminori Kimura

Tokyo metropolitan Komagome Hospital Division of Hepatology

kiminori_kimura@tmhp.jp03-3823-2101

Outcome results