View clinical trials related to Hepatitis.
Filter by:The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).
The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.
Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.
Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are characterized by a spectrum of pathological conditions ranging from an early stage of inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large differences in age and ethnic groups, while it is well known that HCV infection is a major cause of chronic liver disease in Western countries. For both diseases the progression of liver damage is in close correlation with the lifestyle of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was shown that feeding imbalances may have implications in altering the normal immune functions of the subjects, suggesting that the metabolic and the immune systems are closely related to each other. Although it is well known the negative role of obesity on the progression of NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to the immune response is not yet fully understood. Insulin resistance, altered lipid metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection. Recent studies suggest that the evolution of viral infections and chronic inflammation in NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17 (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV infection in the activation of Th17 cells and in the alteration of some of their functions, will allow to shed light on the pathogenic mechanisms underlying the progression of immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17 cells may have a role in the diminished response to therapy in patients who have high cholesterol levels. If the results will confirm our hypothesis, this study will provide useful informations for the clinical management of patients with both steatosis and chronic HCV infection. The data obtained can also be used for the development of new therapeutic strategies directed to modulate the antiviral immune response. All patients will undergo clinical and instrumental assessment depending on the type of pathology. Patients will be required to follow a normocaloric low cholesterol diet for a period of 30 days. The prospective clinical study does not present any form of additional risk for the patients and will be conducted in accordance with the principles established by the Declaration of Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require any additional costs.
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1, 1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B carrier rate as well as liver diseases among children and adolescents. The sexual transmission route is another important way of hepatitis B infection aside from the mother and child vertical infection, especially for youth and adults. Hepatitis B vaccination cohort refers to those who were born after 1986 and received hepatitis B vaccine immunization during newborn period. They are gradually entering into young adults and adolescent age. Among them, there is no empirical evidence to show the actual infection rate and to help implement hepatitis B vaccine booster policy for those who had three seronegative viral markers of hepatitis B. Therefore, the study design is to collect three consecutive years graduate school students school entry health examination data and undergo three hepatitis B viral markers checkup and blood types. The data linkage includes their health checkup data in the freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy and birth record registry, Taiwan cancer registry and Taiwan death record registry.
This research puts liver biopsy as the enrollment screening criteria and the primary efficacy assessment indicators. Patients at different developmental stages of hepatitis B related liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the advantage-treated population and to establish a treatment program, which can save national medical resources, for clinical application of Traditional Chinese medicine Diagnosis and Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to build automation pathological analysis and diagnosis systems and non-invasive clinical assessment criteria and models of liver fibrosis which can be applied in clinical. It can also help to realize electronic patient data collection and management, to establish patients management centre and follow-up database. Then it will help to improve clinical efficacy of being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis B-related mortality, to prolong patients' survival and improve patients' quality of life, to make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering chronic hepatitis B-related liver fibrosis, increase by 15% or more .
Currently, there are several antiviral treatments effective for suppression of viral replication but still failed to cure HBV infection in patients with chronic hepatitis B (CHB). Seven drugs have been worldwide approved for the treatment of CHB at present: conventional IFN (IFN) alfa, lamivudine (LAM), adefovir dipivoxil (ADV), pegylated IFN (Peg-IFN) alfa, entecavir (ETV), telbivudine (LdT) and tenofovir (TDF). Conventional or Peg-IFN alfa monotherapy has a narrow range of efficacy, is associated with several adverse effects and is inconvenient because of frequent injections. Oral nucleot(s)ide analogues (NA) are better tolerated; but virologic response to NA is frequently not durable and prolonged treatment is associated with the emergence of drug-resistant HBV mutants. Although the best treatment choice for CHB is not clarified yet, certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C or human immunodeficiency virus (HIV) infection. A major advancement in treating hepatitis C or HIV infection has been the development of combination therapy. Combination therapy has ever been investigated in patients with CHB, but again the optimal strategy remains to be identified. Entecavir, a carbocyclic deoxyguanosine NA, is one of the most potent anti-HBV agents ever discovered. In addition, the 6-year drug resistance rate is 1.2% in selected lamivudine-naïve cohorts. Pegylated interferon alfa-2a possesses both antiviral and immunomodulatory effects. Overall, satisfactory virologic and serologic responses could be achieved using pegylated IFN alfa in around 30-44% of these patients. Whether the combination therapy using Peg-IFN alfa-2a plus ETV can achieve a long-term beneficial effect against ETV or Peg-IFN alfa-2a alone is not clarified. A prior single-arm pilot study suggested that similar combination therapy may be beneficial in patients with CHB. In this proposal, the investigators thus hypothesize that the efficacy by using combination therapy with Peg-IFN alfa-2a plus prolonged ETV is superior to that by using ETV or Peg-IFN alfa-2a alone in that Peg-IFN may restore host immunity against HBV and prolonged ETV can maximize viral suppression. The objective of this clinical trial is to evaluate the efficacy of the combination of Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg daily for 48 weeks followed by ETV 0.5 mg daily monotherapy for an additional 96 weeks versus ETV 0.5 mg daily monotherapy for 144 weeks or Peg-IFN alfa-2a 180 mcg per week for 48 weeks in patients with HBeAg-negative CHB. It will be an open-label, randomized, comparative, multi-center clinical trial. The recruited patients will be equally randomized into three treatment groups. Treatment-free follow-up period will be 48 weeks in both groups of patients. The primary parameter is the "Simultaneous achievement of HBsAg titer below 100 IU/ml and HBV DNA below 300 IU/ml at 144 weeks after start of treatment", by an intention-to-treat analysis. Genotypic and virologic resistance to ETV will also be assessed at baseline and at end of years 1, 2 and 3. The investigators anticipate that the rate of HBsAg <100 IU/mL plus HBV DNA <300 IU/mL at 3 years of the study period will be 30% for patients receiving Peg-IFN therapy and increased to be 45% for patients receiving Peg-IFN plus entecavir therapy. With a 5% nominal significance level (two-sided), 163 patients per group under a 1:1:1 ratio will provide 80% power to detect a difference of 15% in treatment response rates between group I and III. Because this will be a 4-year study for each patient, the investigators thus anticipate that the dropout rate may be as high as 10%. Accordingly, a total of 540 (180x3) patients will be recruited, in order to account for a dropout rate of up to10%.
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used. The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.