The analysis of the factors related to efficacy of asunaprevir and daclatasvir hydrochloride for hepatitis C-related liver disease - antiviral therapy with asunaprevir and daclatasvir hydrochloride

Kanazawa University0 sites300 target enrollmentFebruary 26, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2015

End Date

September 30, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.