View clinical trials related to Chronic Hepatitis C Infection.
Filter by:This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.
The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.
This is a Phase 3b, open-label, multicenter study to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12), in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts. Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure. Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.
Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who show sustained virologic response (SVR) to treatment including direct-acting antivirals (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to determine the frequency of adverse events, including those that are severe and/or cause treatment interruption, in DAA-based therapy in this setting. Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology (SEIMC). Study population: HCV-monoinfected patients that initiate DAA-based treatment outside clinical trials. Variables: The primary efficacy outcome variable is the proportion of patients who reach undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety outcome variable is the percentage of subjects who discontinue therapy due to adverse events. Statistical analysis: A descriptive study will be performed, as well as a double sensibility analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included in a logistic regression analysis in which SVR12 will be the dependent variable.
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
A study to evaluate chronic hepatitis C infection in cirrhotic adults with genotype 1b infection.
This is a multi-centre prospective longitudinal cohort study with the aim of collecting and storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs for hepatitis C therapy.
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.