Chronic liver disease with hepatitis C virus (chronic hepatitis and compensated cirrhosis)
Conditions
Interventions
Daclatasvir and asunaprevir combination therapy (daclatasuvir 60 mg/day and asunaprevir 200mg/day) for 24 weeks
Sponsors
Iwate medical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient who was clinically diagnosed with chronic hepatitis or compensated cirrhosis (Child-Pugh grade A). HCV serotype 1(genotype 1b or 1a) and serum HCV RNA are positive. Men and women aged 20 to 85 years with HCV genotype 1. Patient which will fall under either of the below:a)CCr for 24 hours; equal or over 30mL/min. b)eGFR;equal or over 30mL/min/1.73 m2. Patient who can orally take in. Patient who has no history of hepatocellular carcinoma (HCC) or no evidence of recurrence after HCC treatment at least one year. Written informed consent was obtained.
Exclusion criteria
Exclusion criteria: Previously treatment with daclatasvir and asnaprevir or other NS5A replication complex inhibitor. Decompensated cirrhosis (i.e.Child Pugh grade B or C cirrhosis). Untreated variceal hemorrhage, hepatic encephalopathy or uncontrollable ascites. HBs antigen and or human immunodeficiency virus antibody are positive. Current hepatocellular carcinoma diagnosed by US, CT or MRI(=<1 year from enrollment). Severe or uncontrolled disorder (i.e. myocardial infarction, heart failure, arrhythmia, cerebral infarction). Gastrointestinal disorder that could interfere with the absorption of the study drugs. Significant drug allergy (such as anaphylaxis or hepatotoxicitys). Advanced cancer untreated or during treatment. History of organ implantation.Findings of organ failure or unstableorgan functio. Woman in pregnancy or having a possibility that she may be in pregnancy, in nursing. Woman having a possibility of fertility or male whose partner has a possibility of fertility cannot use birth control between first treatment day and 6 months after treatment. Man whose partner is in pregnancy cannot use condom between first treatment day and 6 months after treatment. Abnormality in following laboratory tests: AST>5 times UNV, Total bilirubin>=5 mg/dL, Albumin>3 g/dL, Platelet=<50000/mm^3. Patient taking an incompatible drug. Patient restricted by legal reason. Unsuitable case judged by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of sustained virological response (SVR) 24 weeks after end of treatment (EoT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Disappeared rate of HCV RNA during the treatment, EoT and SVR12. Frequency of adverse effects (grade 3 and over) Fasting glucose, insulin, HOMA-IR before and after treatment | — |
Countries
Japan
Contacts
Public ContactYuichi Yoshida
Iwate medical university Division of hepatology, department of gastroenterology
Outcome results
None listed