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

NCT ID: NCT00375661

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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interferon

Group Type NO_INTERVENTION

interferon-alfa-2b and ribavirin

Intervention Type DRUG

Interferon, pnce per week plus daily ribavirin

Interventions

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interferon-alfa-2b and ribavirin

Interferon, pnce per week plus daily ribavirin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University

OTHER

Sponsor Role lead

Responsible Party

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Hiroyuki Marusawa

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsutomu Chiba, M.D.,Ph.D.

Role: STUDY_CHAIR

Kyoto University Hospital

Locations

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Department of Gastroenterology and Hepatology, Kyoto University Hospital

Kyoto, , Japan

Site Status

Osaka Red Cross Hospital

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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O2006-415

Identifier Type: -

Identifier Source: org_study_id

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