View clinical trials related to Hepatitis C, Chronic.
Filter by:This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.
This prospective, national, multicenter, non-interventional study will examine the use of triple combination therapy with boceprevir, Pegasys and ribivarin in re-treating patients with genotype 1 CHC infection. Dosing and treatment duration are at the discretion of the investigator in accordance with local clinical practice and local labeling. Patients will be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection. Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection. The investigators therefore hypothesise that: i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo. ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.
Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. Current combination therapy of pegylated interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial side effects. The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants resistant to host immune responses. Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral approach for prevention and treatment of HCV infection (European patent application EP 08 305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature Medicine 2011). Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with HCV. Following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.
1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. 3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.
The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is justified on the basis of scientific and medical reasons. There are data in multiple animal models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and induces regulatory T cells and immune-modulation as desired in clinical studies. These observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone induced the desired immune-modulation in terms of immunological markers for regulatory T cells and appropriate rises and declines in certain cytokine levels.
The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines 1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether Vitamin D levels predicts negative treatment outcome.
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines 1. whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether Vitamin D levels predictes negative treatment outcome.