The analysis of the factors related to efficacy of asunaprevir and daclatasvir hydrochloride for hepatitis C-related liver disease
- Conditions
- HCV-related liver diseases
- Registration Number
- JPRN-UMIN000016633
- Lead Sponsor
- Kanazawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method antiviral effect (sustained viral responce rate 24 weeks after treatment)
- Secondary Outcome Measures
Name Time Method 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