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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375661
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Hiroyuki Marusawa, 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma
Study Start Date : September 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: interferon Drug: interferon-alfa-2b and ribavirin
Interferon, pnce per week plus daily ribavirin

Primary Outcome Measures :
  1. Incidence of adverse effect of interferon [ Time Frame: During the treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hiroyuki Marusawa, Associate professor, Kyoto University Identifier: NCT00375661     History of Changes
Other Study ID Numbers: O2006-415
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Hiroyuki Marusawa, 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