View clinical trials related to Hepatitis B.
Filter by:- HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA. - HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC. - There is an impaired immune response to HBsAg and HBV vaccine is an easily available, cost-effective, non-harmful method of stimulating immunity.
Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF （tenofovir） or LDT（telbivudine） to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV. Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly. Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating. Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows: A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients. B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy. C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy. D, To compare MTCT rate and adverse effects between LDT and TDF.
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a single oral administration of different doses of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are estimated;3.By measuring the changing drug concentration in the plasma of PNA after a multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters of multiple-dose are estimated, and a basis for dosage regimens of the clinical research phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the changes of concentration of PNA in plasma after high-fat and high-calorie food.
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The investigators also aim to determine adherence to daily TDF in pregnancy as new interventions must not only be effective but also safe, feasible and acceptable in the local, and ideally global, context. Study Design: One arm, open label, Tenofovir treatment intervention study Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their offspring Planned Sample Size: 170 Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA positive women who start TDF late in the first or early in the second trimester. Outcome Measures Time in months to HBV DNA < 100 IU/ml Secondary Objectives 1. To estimate the proportion of women with HBV DNA <100 IU/ml at delivery. 2. To estimate the TDF levels at delivery in women who are HBV DNA detectable and undetectable. 3. To monitor safety of TDF in the Thailand-Myanmar border women 4. To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV. 5. To determine the rate of hepatic flares post-partum. 6. To estimate the proportion of cases of vertical transmission at 2 months of age. 7. Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6 and 12 months
Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) could improve survival rate in patients with acute liver failure and obtain higher HBsAg seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB) patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus GM-CSF in patients with CHB compared to ETV monotherapy.
Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.
Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing antiviral therapy and the interval of clinical monitoring is uncertain. 25% of the Hong Kong population has prior HBV exposure. The investigators plan monitor this cohort of patients and determine (1) the optimal time point for starting antiviral therapy based on the progression of HBV reactivation, and (2) the optimal interval of clinical monitoring.