View clinical trials related to Hepatitis C.
Filter by:This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients. 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.
The 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.
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.
The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.
The role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis C is not established. The study aims to define whether the dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the antiviral immune response they generate. The hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis C with pegylated Interferon and Ribavirin.
This is a prospective randomized controlled trial comparing two different clinic models for patients with hepatitis C. These patients commonly have mental health problems that are barriers to receiving HCV treatment. Patients giving informed consent will be randomized to a usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health practitioner who will address psychiatric and substance use issues with the goal of enabling patients to undergo effective antiviral therapy. The major outcome of the study is the number of patients in each group who are "cured" with antiviral therapy. Patients in both groups receive current standard of care.
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
Up to 120 patients with chronic hepatitis C will be enrolled in a study of viral kinetics and liver gene expression before and during combination therapy with peginterferon and ribavirin. Adult patients with chronic hepatitis C virus (HCV) infection who have compensated liver disease and have not received interferon in the past will be randomized into one of four groups. Groups A and C will undergo liver biopsy before starting peginterferon therapy and Groups B and D will undergo biopsy 6 hours after the initial dose of peginterferon. Furthermore, Groups C and D will receive a run-in period of 4 weeks of ribavirin therapy before starting peginterferon. All patients will receive the standard recommended doses of peginterferon alfa 2a (180 mcg sc weekly) and ribavirin (1000 or 1200 mg daily for genotypes 1, 4-6 and 800 mg daily for genotype 2 and 3) for up to 48 weeks (24 weeks for genotype 2 and 3). All patients in Groups C and D, irrespective of genotype, will be pretreated with ribavirin at a dose of 1000 or 1200 mg, depending on patient body-weight. After the initial peginterferon injection, patients will have blood taken and symptoms recorded at 6, 24, 48, 72 hours and weekly thereafter for four weeks to assess viral kinetic response. Liver biopsy tissue taken before or 6 hours after the initial dose of peginterferon will be assessed by standard light microscopy and also subjected to RNA extraction and microarray analysis of mRNA expression. Patients will be monitored carefully during therapy and tested regularly for HCV RNA levels. Therapy will be given for 48 weeks, but will be discontinued early for patients with genotype 1 infection if HCV RNA levels do not decline by at least 2 log IU/ml by week 12 (lack of an early virological response) or do not decline to undetectable levels by week 24 (lack of HCV RNA clearance). Patients with other genotypes with be treated for a full course of therapy regardless of early responses. After completing therapy, patients will be followed at 4 to 8 week intervals and undergo repeat medical evaluation with liver biopsy 24 weeks after stopping therapy. The primary clinical criterion for success of therapy is a sustained virological response, as marked by the absence of HCV RNA from serum at least 24 weeks after stopping. The focus of this study, however, will be on viral kinetics comparing patients who were pretreated with ribavirin (Groups C and D) to those who were not (Groups A and B) as well as on gene expression studies assessing the effects of peginterferon on intrahepatic mRNA profiles by comparing Group A and B and the effects of ribavirin by comparing Group A to Group C and Group B to Group D. Results will also be compared between different HCV genotypes. These studies are aimed at assessing the mechanisms of action of peginterferon and ribavirin against HCV and evaluating the basis for the lack of virologic response to combination therapy.