View clinical trials related to Hepatitis.
Filter by:The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system. The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN and MELD-based scoring systems to evaluate the performances of the ANN prediction.
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.
After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.
Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues (NRTIs) in HCV/HIV-co-infected patients.
Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an estimated number of 180 million infected patients. Until 2012 the current standard of care (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir and boceprevir as first directly acting HCV drugs have been approved by the local Swiss authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However, therapy success is strongly limited in null-responders (NR) to previous PR. Treatment of HCV-HIV co-infected individuals with the new PI's is accompanied by additional challenges (e.g. drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis are at highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and prompt initiation of treatment is strongly recommended. Recently, data in mono-infected patients showed, that in prior non responders a 12 week course of a triple therapy (TT) with telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These patients urgently need additional therapeutic options with the goal to eradicate HCV in order to prevent further fibrosis progression and to reduce morbidity and mortality. A promising substance in the field of drugs targeting the HCV replication is silibinin. Silibinin is the main component of silymarin, an extract of the milk thistle Silybum marianum. Intravenous silibinin (iSIL) targets multiple steps in the virus life cycle and exhibits anti-oxidant, anti-inflammatory, anti-viral and immunomodulatory properties. iSIL inhibits the HCV NS5B polymerase activity directly or by interfering with the binding of RNA to this enzyme. In addition, iSIL appears to block virus entry, virus transmission and virus secretion.In 2008 Ferenci et al. for the first time reported the substantial clinical antiviral-effect of intravenous silibinin (iSIL) against HCV in PR non-responders. The administration of 20mg/kg iSIL in 20 patients led to a highly significant decrease in viral load. We intend to investigate the effect and tolerability of iSIL in HIV-HCV co-infected individuals with advanced liver fibrosis and previous non- or partial response to SOC. All included study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day (expressed as silibinin concentration) once a day for 14 days. At the end of the THISTLE study, i.e. after the day of completion of the 14-day iSIL administration (day 15), the patients will be considered for eligibility to receive standard of care. We assume that the decline in HCV viral load would substantially improve the chances of SVR as the reduction of viral load should both increase the efficacy of PR and reduce the odds of drug resistance to HCV-specific protease inhibitor. - Trial with medicinal product
The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.
The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.