An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection...
Hepatitis CChronicThis multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.
An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With...
Hepatitis CChronicThis prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
Observational Study in HCV Chronic Infection
Hepatitis CChronicHCV infection is the most frequent cause of liver chronic disease, cirrhosis and hepatocellular carcinoma in western countries. To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4, and is associated with important adverse side effects, that lead to treatment interruption in approximately 30% of cases. The recent association of first generation HCV- specific direct-acting antiviral agents (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates, also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV. While several new DAAs are in development, the ultimate goal is represented by IFN-free regimens, that will provide a great advantage in terms of patients adherence to therapy and quality of life. In this context, prospective observational studies are needed to evaluate the real and long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety, costs and impact on patients quality of life. Italy is the European country with the greatest number of HCV infected people (average, 3% of population), with higher prevalence in the center and in the south of the country, especially in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype 1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the end of 2012. For these reasons, Italy represents an interesting context for collecting data on long-term efficacy, safety and tolerability of new anti-HCV treatments. The PITER cohort study, developed in the frame of Italian Platform for the study of the therapy of viral hepatitis a prospective observational study, is based on a large cohort of HCV infected patients from more than 100 clinical centers distributed on the whole national area. The main aims of the PITER longitudinal cohort study are: 1) to produce of an ongoing and continuously updated picture of the changing epidemiology of HCV infection in the country; 2) to evaluate in a real-life setting the expected impact of DAAs on the natural course of infection and on long-term morbidity and mortality.
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis...
Hepatitis CChronicThis retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.
A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
Hepatitis CChronicThis Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor...
Chronic Hepatitis CThe purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding...
Hepatitis CChronic1 moreThe objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
sgp130 in Chronic Human Liver Disease
Alcoholic Liver DiseaseChronic Hepatitis C Virus InfectionChronic liver disease are characterized by increased levels of plasma IL-6, but the bioactivity of this cytokine in this disease is not well known. IL-6 receptor complex is regulated by multiple receptors subunits: the soluble form of IL-6 Receptor enhance IL-6 signal by a process called trans-signaling on cells expressing few membrane IL-6 receptors. Soluble gp130 is the natural inhibitor of IL-6 trans-signaling. The aim of this study is to characterize circulating and liver levels of theses compounds of IL-6 receptor complex, to unravel the bioactivity of IL-6 in this disease.
Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha...
Hepatitis CChronicTo study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
Alcoholic Liver DiseaseChronic Hepatitis C VirusAlcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.