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 recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Kyoto University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hiroyuki Marusawa, Kyoto University
ClinicalTrials.gov Identifier:
NCT00375661
First received: September 12, 2006
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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 ]

Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: September 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00375661

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

No publications provided

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: April 5, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University:
hepatocellular carcinoma

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

ClinicalTrials.gov processed this record on October 29, 2014