View clinical trials related to Chronic Hepatitis B.
Filter by: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.
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.
Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).
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.
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea. The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea. The investigators plan to collect 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).