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

Hepatitis C, Chronic Clinical Trial

Official title:

Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375661
• Other study ID #: O2006-415
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2006
• Last updated: September 1, 2015
• Start date: September 2006
• Est. completion date: March 2013

Study information

• Verified date: September 2015
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis C, Chronic

Intervention

Drug:
• interferon-alfa-2b and ribavirin
Interferon, pnce per week plus daily ribavirin

Locations

Country	Name	City	State
Japan	Department of Gastroenterology and Hepatology, Kyoto University Hospital	Kyoto
Japan	Osaka Red Cross Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse effect of interferon		During the treatment period	Yes