View clinical trials related to Hepatitis B, Chronic.
Filter by:More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.
Background: - Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end stage liver disease and liver cancer. Although significant progress has been made recently in hepatitis B therapy, current knowledge about how to manage the infection is limited because most treatment trials involve 1 to 2 years of therapy at most, even though most patients require treatment of much longer duration for optimal long-term outcome. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B. Objectives: - To study individuals with hepatitis B and identify factors that affect the way the disease progresses. Eligibility: - Individuals at least 18 years of age who have been diagnosed with hepatitis B. Design: - Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors, and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will provide biopsy material for further study. - Information will be collected during a series of study visits. Each visit will take approximately 1 hour. During the first year, participants will have study visits 12 weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years, participants will have a study visit approximately every 24 weeks (6 months) until the end of the study. - Additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study. - Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits.
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.
This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.
This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG monotherapy in non-cirrhotic adults with chronic hepatitis B virus (HBV). The study will consist of 2 phases for participants in the TDF+PEG 48 week, TDF 48 week+PEG 16 week, and PEG 48 week groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those with new signs and/or symptoms will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.
Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection. This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.
No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.
This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. The primary objective of this study is to evaluate the long-term antiviral efficacy of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate the safety and tolerability of TDF including the biochemical and virological responses to TDF, the incidence of drug resistance mutations in these patients The duration of treatment in this study is total of three Years (144 weeks) on TDF.
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.