View clinical trials related to Hepatitis B, Chronic.
Filter by:Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.
This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
Background: - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help. Objective: - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications. Eligibility: - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral medicines for hepatitis B for at least 4 years. Design: - Participants will be screened with physical exam and medical history. They will complete health questionnaires about their levels of fatigue and pain. They will have blood and urine tests. They may have an eye exam. - Participants also will have a Fibroscan. A test to measure how stiff your liver is. - Eligible participants will have a liver biopsy. Blood will be drawn. - Participants will be admitted to the NIH Clinical Center. They will be injected with the study drug. Then they will have a second liver biopsy. They will be discharged 24 hours later. - Participants will give themselves study drug injections under the skin weekly for 24 weeks. - Participants will have 5 clinic visits during the 24-week treatment period. Then they will have follow-up visits every 12 weeks for 48 weeks. - During visits, participants may have a physical exam and medical history. They may have blood and urine tests. They may have a Fibroscan and complete questionnaires. At the final visit, they will also have a Fibroscan.
This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3 groups to receive different antiviral treatment.
Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study. Secondary Objectives: To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients. Methodology: Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.