View clinical trials related to Hepatitis B.
Filter by:The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS9950. The study will be conducted in three parts sequentially: Part 1, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of single and multiple doses of HRS9950 tablet in healthy subjects. Part 1 will consist of 64 healthy subjects, 6 groups. Part 2, evaluate food effect of HRS9950 in healthy subjects. Part 2 will consist of 14 healthy subjects, 1 group (one of groups in Part 1). Part 3, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS9950 tablet in naïve and treatment-experienced chronic hepatitis B (CHB) patients. Part 3 will consist of 40 CHB patients, 1 group for naïve patients and 3 groups for treatment-experienced patients.
This study is being done to determine if healthcare workers who have previously failed to respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant (hepB-CpG) (Heplisav-B)
This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.
Anti-HBc positive liver donors frequently have occult HBV infection, and several studies in HBsAg-negative subjects have shown that there is often the detection in the liver of covalently closed circular DNA (cccDNA). In the setting of liver transplantation and immunosuppresion, grafts from antiHBc positive donors may cause de novo HBV infection (defined by the development of positive HBsAg and/or detectable serum or liver HBV DNA in previously HBsAg recipients). Active immunization may be successful in up to 20% of patients who received an anti-HBc+ liver during transplantation after the first vaccination schedule, and up to 30% after a second vaccination course. Responders to vaccination could safely halt nucleos(t)ide analog prophylactic therapy with no risk of HBV reactivation during follow-up. We also hypothesize that an impaired antigen-specific adaptive cell-mediated immunity at baseline explain the lack of response Primary objective: 1. To investigate the efficacy of HBV vaccination in liver transplant recipients who received a liver from an anti-HBc positive donor. 2. To assess the safety of nucleos(t)ide treatment interruption in those patients achieving a response to HBV vaccination
The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis,and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis,and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to evaluate the existence of immune protection in healthy children with negative hepatitis B surface antibody and find a method to evaluate the immune protection induced by hepatitis B vaccine.
A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure. In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .
Chronic hepatitis B (CHB) infection affected 292 million individuals in the world, translating to about 3.9% of global prevalence. Up to 40% of patients with CHB will develop liver-related complications. Many patients require long-term oral antiviral therapy since off-treatment sustained virological control can only be achieved in a minority of patients. It is uncommon for patients taking long-term antivirals to be able to stop the treatment if favorable factors are not present. Those include low viral load, long enough duration of treatment, and absence of cirrhosis. Some studies have found that inducing a mild flare is beneficial for achieving functional cure in chronic hepatitis B infection. There is lack of data in the immunological and virological profile in patients who stop their long-term antiviral therapy, and in those who developed flare after treatment cessation.
Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: - To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV) - To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group - To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group - To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV - To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™ - To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines