Chronic hepaititis due to HCV Compensated liver cirroshis due to HCV
Conditions
Interventions
Harvoni once daily for 12 weeks
Sponsors
Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with chronic hepatitis or compensated cirrhosis due to HCV infection 2)HCV genotype 1/serotype 1 3)Patients 20 years of age or older at the time of informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of New Biomarkers for Prediction of Hepatocellular Carcinoma after eliminating Hepatitis C Virus | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTetsuro Shimakami
Kanazawa University Department of Gastroenterology
Outcome results
None listed