Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects...
Hepatitis CThe purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.
HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b
Chronic Hepatitis CSustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This observational study was carried out on a large group of "naïve" HCV patients to evaluate difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon (Peg-IFN) plus ribavirin.
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep...
Hepatitis CThe purpose of this study is to monitor the cardiovascular and renal health of patients who previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to hepatitis C infected patients who have never taken BMS-986094.
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis...
Hepatitis CThis non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.
Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic...
Hepatitis C ChronicThis is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1. As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.
Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic...
Chronic Hepatitis C Viral InfectionThe working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.
Pharmacogenomic Research in Korean Patients With Hepatitis C
Chronic Hepatitis CThe aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.
Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin...
Hepatitis CHepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Recently particular polymorphisms of IL-28B gene were reported to correlate with histological recurrence and antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar results have not been described yet in living donor liver transplant patients. There is data suggesting slightly inferior outcomes in living donor liver transplants when done for hepatitis C. The investigators postulate that such inferior outcomes may be related to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive similarly unfavorable polymorphism livers from their relatives).
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic...
Hepatitis CChronicThis observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.
Chronic Hepatitis C and Insulin Resistance
Hepatitis CInsulin ResistanceChronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC