An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis

NCT02195440•Komagome Hospital

Summary

The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.

Detailed Description

This is a single-center, open-label, continuous i.v. administration, dose escalation Phase I study in patients with hepatitis C cirrhosis. One cycle consisted of one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. One cohort was a total of six cycles, a 12-week treatment period. PRI-724 was administered at a dose of 10 mg/m2/day in Cohort 1, 40 mg/m2/day in Cohort 2, and 160 mg/m2/day in Cohort 3 in a dose escalation manner. Each cohort was to include 6 subjects.

Eligibility

Age

20 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Presence of cirrhosis due to hepatitis C virus. 1) Serum HCV-RNA test positive 2) Definitive diagnosis of cirrhosis established by liver biopsy (HAI score: Grade IV-D).
•2. Child-Pugh Class A or B at the time of informed consent, with no likelihood of improvement with existing medical treatment.
•3. Performance Status: 0 - 2.
•4. Between =\>20 and \<75 years of age at the time of providing written consent.
•5. Having provided voluntary written consent for participation in this study.
•6. Esophageal and gastric varices are well controlled

Exclusion Criteria

•1. Patients with cirrhosis due to causes other than hepatitis C virus; or patients with cirrhosis due to unknown causes.
•2. Patients with a history of primary liver cancer or a complication thereof.
•3. Patients with a complication of malignant tumor or a history thereof (within 5 years prior to screening).
•4. Patients in whom such active viral infections as HBV, HIV or ATCL or syphilis infection cannot be ruled out.
•5. Patients with serum creatinine \>1.5 times over upper normal or creatinine clearance =\<60 mL/min/1.73 m2.
•6. Patients with hemoglobin \<8 g/dL.
•7. Patients with platelet count \<50,000 /\µL.
•8. Patients with T.Bil =\>3.0 mg/dL.
•9. Patients with a complication of poorly controlled diabetes, hypertension or heart failure.
•10. Patients with a complication of mental disorder requiring treatment.
+9 more criteria

Locations (1)

Tokyo metropolitan Komagome Hospital

Tokyo, Japan

Key Dates

Start Date

August 1, 2014

Primary Completion Date

March 31, 2017

Completion Date

March 31, 2017

Last Updated

July 7, 2022

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus-infected Cirrhosis

Interventions

PRI-724

DRUG