View clinical trials related to Chronic Hepatitis B.
Filter by:This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in Chronic Hepatitis B Patients.
Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in France and are among the most exposed to HIV infection and hepatitis B. The Parcours study aims to understand, among sub-Saharan African migrants, how social and individual factors combine in the course of migration and settlement in France, and influence the risk of infection, access to prevention and care, and the effectiveness of care for both HIV and hepatitis B diseases. The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants reside. It consists in a cross-sectional observational survey, using a life-event history approach that reproduces the sequence of different life and health events, and contributes to explain the present situation (type of disease management, patient's quality of life) in light of all the elements of the past trajectory (administrative, familial, socio-economic, professionals). A representative survey was conducted between February 2012 and May 2013 in health care facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group living with HIV, a group living with chronic hepatitis B and a group who has neither of these diseases. For each group, stratified random sampling was used. The survey was conducted in 24 hospital services providing HIV care, 20 health care facilities providing hepatitis B care, and 30 primary health care facilities. Were eligible all patients attending these health care facilities, born in a Sub-Saharan African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group). Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by hepatitis B, and 763 patients without these two diseases participated in the study. For all participants, detailed information on socio-demographic characteristics; migration and life conditions in France; social, sexual and reproductive life history; and screening and care history were collected using a life-event history questionnaire administered face-to-face by a specialized interviewer. Health care professionals documented clinical information from the medical records. Data was collected anonymously.
NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated HBsAg clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha 2a to restore host immunological control of HBV infection. REP 2165 is a version of REP 2139 which has been shown preclinically to retain antiviral activity with lower accumulation in the liver. Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate complexes, which improve their administration tolerability. This open label, randomized and controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir disoproxil fumarate and pegylated interferon alpha-2a.
This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.
Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but only about 30-40% remain sustained response 1-3 years after discontinued therapy. The investigators will try to improve the sustained response rate by given a course of HBV vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir therapy. Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are suppressed during entecavir or tenofovir therapy. Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30 months will be invited to this study. The case group will receive 5 Engerix-B injections during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group: 75 cases will be enrolled to receive Engerix-B injection and compared with histological non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be randomized into case (vaccine) and control group according to age, gender, pretreatment HBV DNA level. Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be discontinued after completed therapy. Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy. Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL after discontinued nucleos(t)ide analogues therapy will be considered to have sustained response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously without further therapy will be defined as delayed response. Patients with persistent HBV DNA greater than 1*100000 cps/mL will be considered to have non-sustained response. Study duration: The enrollment will be completed in one year and keep on observation for additional 2 years. Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may decrease the HBV relapse rate at 1 and 2 year after completed therapy.
Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.
Background: - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help. Objective: - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications. Eligibility: - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral medicines for hepatitis B for at least 4 years. Design: - Participants will be screened with physical exam and medical history. They will complete health questionnaires about their levels of fatigue and pain. They will have blood and urine tests. They may have an eye exam. - Participants also will have a Fibroscan. A test to measure how stiff your liver is. - Eligible participants will have a liver biopsy. Blood will be drawn. - Participants will be admitted to the NIH Clinical Center. They will be injected with the study drug. Then they will have a second liver biopsy. They will be discharged 24 hours later. - Participants will give themselves study drug injections under the skin weekly for 24 weeks. - Participants will have 5 clinic visits during the 24-week treatment period. Then they will have follow-up visits every 12 weeks for 48 weeks. - During visits, participants may have a physical exam and medical history. They may have blood and urine tests. They may have a Fibroscan and complete questionnaires. At the final visit, they will also have a Fibroscan.
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.