Back to resultsLow-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
interferon-alfa-2b and ribavirin
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis C, Chronic focused on measuring hepatocellular carcinoma
Eligibility 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
Sites / Locations
- Department of Gastroenterology and Hepatology, Kyoto University Hospital
- Osaka Red Cross Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
interferon
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse effect of interferon
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00375661
Brief Title
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
Official Title
Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
hepatocellular carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interferon
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
interferon-alfa-2b and ribavirin
Intervention Description
Interferon, pnce per week plus daily ribavirin
Primary Outcome Measure Information:
Title
Incidence of adverse effect of interferon
Time Frame
During the treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsutomu Chiba, M.D.,Ph.D.
Organizational Affiliation
Kyoto University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology, Kyoto University Hospital
City
Kyoto
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
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