View clinical trials related to Hepatitis A.
Filter by:- The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis. - The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients
This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients. The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with Engerix-B Dialysis patients will be categorized as "naïve" or "previously vaccinated" and each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be administered via intra-muscular injection to the deltoid muscle. The study will consist of three periods: a screening period of up to four weeks, a 24-week open-label treatment period, and a 24-week safety follow-up period. The total expected duration of the study per subject is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks; and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B. Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations calculated for all subjects upon last active dose; the proportion of subjects with anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first vaccination. A by-vaccine comparison of adverse events will also be performed.
Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection
Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.
The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation. Study Hypotheses: - Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture - HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma. - PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy - There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.
Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants. Out of range of clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers with persistently normal ALT and viral load more than 10^5 copies/mL have progression of liver disease during long-term follow-up. In addition, certain proportions of these patients do have significant inflammation and fibrosis in liver histology. This study will be able to identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding improvement of liver histology during short-term (1-year) and long-term ETV treatment (3-year).
Background: - There are two forms of chronic hepatitis B. The difference between the forms is whether or not a viral protein called hepatitis B e antigen is present in the blood. Standard approaches to treating both forms of chronic hepatitis B involve different drugs. One drug is called peginterferon, another is called tenofovir DF. These drugs are often given separately and used for different forms of the disease. However, researchers want to see if combining peginterferon and tenofovir DF will be a more effective treatment than tenofovir DF alone. Objectives: - To see whether combining tenofovir DF and peginterferon, or using tenofovir DF alone, is a more effective treatment of chronic hepatitis B. Eligibility: - Individuals at least 18 years of age who have chronic hepatitis B and are in the Hepatitis B Research Network Cohort study. Design: - Participants will be screened with a physical exam and medical history. Blood, urine, and liver tissue samples will be collected. Bone and liver imaging studies will also be performed. - Participants will be divided into two groups. One group will have tenofovir DF alone for 192 weeks (about 4 years). The other group will have tenofovir DF and peginterferon for 24 weeks (about 6 months), and then tenofovir DF alone for 168 weeks (about 3.5 years). - Participants will take the study drugs on the schedule determined by their study doctors. They will keep a diary to record their doses and any side effects. - Participants will have three study visits 4 weeks apart after the starting the treatment. At these visits, they will have a physical exam and provide blood samples. They may also provide urine samples and have imaging studies. - After the first three study visits, participants will continue to have study visits every 12 weeks until the treatment ends at week 192. These visits will have many of the same tests as the first three visits. At some of these visits, they may fill out questionnaires about their quality of life. - Participants who do not respond to the study drugs may have their medications changed. They may also be asked to stop treatment.
This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.