Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC

Phase 4

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: interferon-alfa-2b and ribavirin

• Registration Number: NCT00375661
• Lead Sponsor: Kyoto University

Brief Summary

The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-13
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.
• Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy

Exclusion Criteria

• No recurrence of hepatocellular carcinoma 3 months after the primary treatment
• Renal dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interferon	interferon-alfa-2b and ribavirin	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse effect of interferon	During the treatment period

Trial Locations

Locations (2)

Osaka Red Cross Hospital; 🇯🇵 Osaka, Japan

Department of Gastroenterology and Hepatology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan