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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 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 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:
Hepatitis C
Carcinoma, Hepatocellular
Hepatitis C, Chronic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepatitis, Chronic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on October 27, 2016