Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicine, Harvoni
Not Applicable
- Conditions
- Chronic hepaititis due to HCV Compensated liver cirroshis due to HCV
- Registration Number
- JPRN-UMIN000019801
- Lead Sponsor
- Kanazawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with a history of hypersensitivity to any of the ingredients of HARVONI(CONTRAINDICATIONS in the package insert) 2)Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or those with renal failure requiring dialysis (CONTRAINDICATIONS in the package insert) 3)Patients who are using any of the following medications (Contraindications for Coadministration in the package insert):Rifampicin, carbamazepine, or St. John's wort-containing food 4)Patients with decompensated liver disease (poorly controlled ascites, hepatic encephalopathy, or T-Bil more than or equal to 3.0 mg/dL) 5)Patients who have received treatment for HCC within the past 3 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of New Biomarkers for Prediction of Hepatocellular Carcinoma after eliminating Hepatitis C Virus
- Secondary Outcome Measures
Name Time Method 1)Identification of new biomarkers for prediction of hepatocellular carcinoma after eliminating Hepatitis C Virus 2)Analysis on HCV amino acid/nucleotide sequences (core, NS5A, and NS5B) 3)Analysis on cytokines in peripheral blood 4)Analysis of gene profiling of liver obatained by liver biopsy 5)Analysis of Fibroscan 6)Analysis glucose/lipid metabolism 7)Analysis of gene profiling of peripheral blood lymphocytes