View clinical trials related to Hepatitis B.
Filter by:Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.
The goal of chronic hepatitis B (CHB) treatment is complete and permanent eradication of hepatitis B virus (HBV) from patient's body, which is best represented by serum HBsAg loss accompanied by undetectable serum HBV DNA level. While the most recently approved nucleos(t)ide analogues (NA) have marked antiviral potency and can induce HBV DNA undetectability in the majority of patients through prolonged treatment, NA need to be given long term, almost indefinitely, in most cases because they suppress HBV DNA only during therapy. For example, even after HBeAg-loss by a potent NA, suppression of serum HBV DNA to undetectable level is sustained only in about 23%-37% at 24 weeks off treatment. Thus, continuous therapy with NA until HBsAg clearance remains necessary in a majority of cases. The recent availability of commercial quantitative assays of serum hepatitis B surface antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or entecavir therapy is slower and less pronounced compared to interferon treatment, despite a higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that the predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is more than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear advantage in reducing the treatment duration required to achieve HBsAg-loss. Interestingly, in a recent preliminary study, 24-weeks of treatment with telbivudine has induced HBsAg decline as comparable to pegylated interferon treatment. Although there has been no head-to-head trial comparing NAs in inducing HBsAg decline, previous studies consistently suggested that the decline of HBsAg is greater during telbivudine treatment compared with lamivudine or entecavir. Thus, in this clinical trial, the investigators will investigate whether telbivudine is more effective in inducing HBsAg decline compared with entecavir in HBeAg-positive CHB patients who have achieved undetectable serum HBV DNA by preceding entecavir treatment.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
Background: - Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But the drugs have not yet been approved for long-term use because some of them can have serious side effects. However, stopping treatment too soon can make the infection worse and may lead to more serious forms of liver disease. Researchers have not been able to determine a when to stop treatment. They want to study people with chronic hepatitis B infection to find out the best time to stop treatment and prevent the disease from causing further liver damage. Objectives: - To study the safety and effectiveness of withdrawing antiviral treatment for chronic hepatitis B after at least 4 years of treatment. - To determine whether stopping long-term antiviral treatment for chronic hepatitis B makes the infection worse. Eligibility: - People who are at least 18 years of age; have been taking antiviral drugs to treat chronic hepatitis B for at least 4 years; and are being evaluated to stop treatment. Design: - Those in the study will be screened with a physical exam, medical history, questionnaire, and blood tests. They will remain under the care of their regular doctor during the study. - They will have an abdominal ultrasound to study scarring in the liver, if they have not had one in the past year. - Those without detectable levels of the hepatitis B virus in their blood will stop antiviral treatment. They will have monthly blood tests for the first 6 months to check virus levels, and then every 3 months afterward. - Those whose blood tests show an increase in virus levels will restart antiviral treatment as directed by the study doctors and their personal doctor. - All those in the study will be monitored until the end of the study.
Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in such circumstance according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM, studies on the proper prophylactic antiviral regimen is warranted. The present multicenter, prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.
Animal experiments demonstrated that father might transmit HBV vertically via male germ line, however, whether it is really existed in human remains to be determined. Since HBV is a blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their fetuses carried the virus from fathers. If women had been vaccinated for HBV before conception, what would happen to a maternal immune system if her fetus carried HBV from spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare, the viral replicating status and fetal immune response in uterus are unknown. The aim of study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.