View clinical trials related to Hepatitis B, Chronic.
Filter by:This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 100 Subjects who meet all the selection criteria will be randomly assigned 1:1:1:1:1 to (A) QL007 100 mg QD+ Tenofovir dipirofurate fumarate （TDF）300 mg QD, (B) QL007 200 mg QD+ TDF 300 mg QD, (C) QL007 400 mg QD+ TDF 300 mg QD, (D) QL007 200 mg BID+ TDF 300 mg QD, (E) TDF 300 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 in combination with TDF in HBeAg positive patients with chronic hepatitis b, and to recommend a reasonable regimen for phase III study.
This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 60 Subjects who meet all the selection criteria will be randomly assigned to (A) QL007 200mg BID+ Tenofovir dipirofurate fumarate （TDF）300 mg QD, (B) QL007 200 mg BID+ Entecavir 0.5 mg QD, (C)TDF 300 mg QD, (D) Entecavir 0.5 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 tables in combination with TDF or Entecavir in patients with chronic hepatitis b who have received nucleoside (acid) therapy, and to recommend a reasonable regimen for phase III study.
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 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 more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.
A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
Primary Objective: To evaluate the activity of Antroquinonol in patients with chronic hepatitis B Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with chronic hepatitis B
Most patients with Chronic Hepatitis B are on nucleoside analogy (NA) long term, but this leads to HBsAg loss (defined as functional cure) of only 2% at 6 years. Recently a number of studies have shown significant HBsAg loss rates after stopping nucleoside analogues (NA). However, no criteria to select such patients have been evaluated. Consequently, the objective of the study is not only to determine the proportion of patients able to achieve HBsAg loss in those with qHBsAg≤100IU/ml. The study is designed as a randomised control trial with 1:2 parallel arm randomisation to continuing NA or stopping therapy. Patients will be monitored after stopping therapy for Hepatitis B flares and also to document HBsAg loss.
The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).
Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.