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

This study has been completed.
Information provided by (Responsible Party):
Hiroyuki Marusawa, Kyoto University
ClinicalTrials.gov Identifier:
First received: September 12, 2006
Last updated: September 1, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: interferon-alfa-2b and ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • Incidence of adverse effect of interferon [ Time Frame: During the treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2006
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: interferon Drug: interferon-alfa-2b and ribavirin
Interferon, pnce per week plus daily ribavirin


Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00375661

Department of Gastroenterology and Hepatology, Kyoto University Hospital
Kyoto, Japan
Osaka Red Cross Hospital
Osaka, Japan
Sponsors and Collaborators
Kyoto University
Study Chair: Tsutomu Chiba, M.D.,Ph.D. Kyoto University
  More Information

Responsible Party: Hiroyuki Marusawa, Associate professor, Kyoto University
ClinicalTrials.gov Identifier: NCT00375661     History of Changes
Other Study ID Numbers: O2006-415 
Study First Received: September 12, 2006
Last Updated: September 1, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Hepatitis C, Chronic
Digestive System Diseases
Digestive System Neoplasms
Flaviviridae Infections
Hepatitis C
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016