HCV-related liver diseases
Conditions
Interventions
Asunaprevir Capsule 100 mg twice a day Daclatasvir hydrochloride 60 mg tablet once a day 24 weeks oral administration
Sponsors
Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with CH-C or those with compensated LC-C 2)HCV genotype 1/serotype 1 3)Patients who are treatment-naiveve and ineligible for, or intolerable to, interferon-based therapy Ineligible patients refer to those who could not receive interferon-based therapy due to severe psychiatric disorder, interstitial pneumonia, or autoimmune disease. Intolerable patients refer to those who had previously received interferon but discontinued the drug during the treatment due to adverse reactions 4)Patients who have failed to respond to interferon-based therapy 5)Patients aged >/= 20 years and < 80 years at the time of informed consent 6)Patients who have voluntarily provided written informed consent after fully understanding the information given about participation in the study.
Exclusion criteria
Exclusion criteria: 1)Patients with a history of hypersensitivity to any ingredient contained in asunaprevir and daclatasvir hydrochloride [Contraindications in the package insert] 2)Pregnant women, women suspected of being pregnant, or lactating women [Contraindications in the package insert] 3)Patients who are receiving any of the following drugs [Contraindications for coadministration in the package insert] Rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, systemic dexamethasone, food products containing St. John's wort, azole antifungal agents, clarithromycin, erythromycin, diltiazem, verapamil hydrochloride, drug products containing cobicistat, HIV protease inhibitor, modafinil, non-nucleoside reverse transcriptase inhibitor, bosentan hydrate, cyclosporine, flecainide, propafenone 4)Patients with moderate (Child-Pugh Class B or C) hepatic impairment or those with decompensated liver disease (poorly controlled ascites or hepatic encephalopathy, T.Bil 3.0 mg/dl or above) [Contraindications in the package insert] 5)Patients who are considered by the investigators as inappropriate to be study patients [established for the sake of patient safety]. Patients who meet any of the following criteria will be ineligible for inclusion in the study 6)Patients who received treatment of liver cancer within the past 6 months 7)Patients who are considered by the investigators/subinvestigators as inappropriate to be subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antiviral effect (sustained viral responce rate 24 weeks after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)analysis of HCV sequcenc of core, NS3 protease, and NS5A 2)analysis of expression of non-coding RNA in liver and blood 3)analysis of gene expression of peripheral lympocytes 4)analysis of gene expression of liver 5)analisis of liver stiffness by fibroscan 6)analysis of cytokines in bood 7)analysis of the markers for glucose and lipid metabolism 8)analysis of the function of T lymphocyte related to hepatoma 9)rate of hepatocarcinogenesis and recurrence of hepatoma after antiviral therapy | — |
Countries
Japan
Contacts
Public ContactTetsuro Shimakami
Kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed