Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
- Conditions
- Hepatocellular carcinoma (HCC) with chronic liver diseases by Hepatitis C virus (HCV) infection (after radical HCC treatment)
- Registration Number
- JPRN-UMIN000007668
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(1) Not consent to observe the regulation about concomitant drug and concomitant therapy (2) Patients with complications that influence on serum alanine aminotransferase or aspartate aminotransferase, including polymyositis, acute myocardial infarction, and gallstone. (3) Patients under dialysis therapy (4) Patients with liver diseases due to chronic viral hepatitis (except for Hepatitis C virus), liver failure, alcohol abuse, drug-induced liver damage, autoimuune hepatitis, and primary biliary cirrhosis. (5) Patients with obstruction of bile duct. Patients with severe liver diseases, who meet one of following criteria; # Child-Pugh grade C # Hepatic encephalopathy # Total bilirubin >= 3mg/dL # Decompensated liver cirrhosis # AST >= 500IU/L # ALT >= 500IU/L (6) Patient with any other cancer (7) Patients of porphyria (8) Past history of hypersensitivity for Rifampicin (9) Preceding administration of other investigational agent within 24 weeks before enrollment of this study (10) Patients with pregnancy, lactation or possibility of pregnancy. Not consent to use contraceptive method during the study treatment. (11) Patients with active infectious diseases due to methicillin-resistant Staphylococcus aureus, atypical Mycobacteria, and Mycobacterium tuberculosis (12) Patients under chemotherapy of anti-cancer drug (Local or Systemic) or radiotherapy (13) Preceding enrollment of this study, and preceding administration of Rifampicin in this study (14) Any patients judged by the investigators to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method (1) Serum alanine aminotransferase, (2) Serum aspartate aminotransferase, (3) Serum lactate dehydrogenase, (4) Serum alpha-fetoprotein, (5) Serum lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), (6) Serum protein induced by vitamin K absence or antagonist-II (PIVKA-II), (7) Serum level of Vascular endothelial growth factor, (8) One-year recurrence