View clinical trials related to Hepatitis B.
Filter by:The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction). 2. To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. Chronic maternal HBV infection is an important source of perinatal transmission in regions of high HBV prevalence. In antenatal clinics at Shoklo Malaria Research Unit (SMRU), the Hepatitis B (HB) surface antigen (sAg) prevalence is 8.3% with a HB e-antigen (HBeAg) prevalence of 32.7% in those positive for HBsAg in 2012-2014. Perinatal infection occurs in 70-90% of women with HBeAg positive chronic HBV compared with 0-30% in those with HBeAg negative chronic HBV (inactive carriers). These infection rates reflect, in part, the failure of maternal and child health programs to prevent perinatal transmission with hepatitis B immunoglobulin (HBIG) and HB vaccines. Prevention of mother to child transmission (PMTCT) fails in an estimated 8-32% of cases with adequate preventive techniques. Antiretrovirals, like tenofovir (TFV) that is administered as the prodrug Tenofovir Disoproxil Fumarate (TDF), are active against HBV and may reduce the risk of HBV transmission at birth if offered at the right time in pregnancy. One of the major gaps in implementing this strategy is adequate pharmacokinetic (PK) data in pregnant women that informs correct dosing. One recently published population PK study in 154 women who provided maternal blood samples (32 and 36 weeks of pregnancy, at delivery, and at 1 and 2 months post-partum) reported a tenofovir area under curve (AUC) 0-24 that was estimated to be 20% (95% CI, 19-21%) lower during pregnancy than during post-partum suggesting no dose adjustments are needed in 3rd trimester. Most PK studies for TDF in pregnancy have been for Human Immunodeficiency Virus type 1 (HIV-1) infections. However, these patients often receive additional antiretroviral medications, preventing conclusions on PK parameters of Tenofovir (TFV) alone. Doses that are optimal for HIV may not be appropriate for HBV. When TDF is administered during pregnancy and potentially during lactation, it is important to establish the infant drug exposure. Previous human studies have shown that antiretrovirals administered to lactating mothers are present in the breast milk and have detected a low TDF breast milk concentration representing 0.03% or less of the proposed infant dosage. However, there is no data on this subject in therapeutic treatment of HBV infected women. In resource poor settings TDF administration will be ceased after 1 month post-partum. While there is some understanding of what happens to viral load post cessation in non-pregnant individuals, post-partum TDF cessation is less well understood and may be affected by differences in immunity. With breastmilk as the primary source of nutrition for babies in resource limited settings, it is important to know the viral exposure from breastmilk, if any, as these settings may also have problems achieving birth dose, HBIG and completion of the recommended three doses of vaccine. The investigators propose a dense PK study of once daily TDF 300 mg during pregnancy given for PMTCT of HBV mono-infection. Tenofovir PK will be measured in maternal blood samples in steady-state, in the 2nd and 3rd trimesters and post-partum. The presence of HBV DNA in blood and breast milk will also be explored in women after cessation of treatment until 6 months post-partum.
Aim of the work To estimate frequency of viral HB & C infection in ITP patients who received triple therapy in comparison with another group treated with steroids only. To explore risk factors and routes of transmission of viral HB & C infection in ITP patients who received triple therapy and the another group treated with steroids . - To assess preventive measures of viral HB& C infection in the hematology ward To investigate the influence of viral HB & C infection on clinical picture, response to treatment and side effects in ITP patients who received triple therapy or steroids.
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
The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.
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.
This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.
Inflammatory bowel disease (IBD) has witnessed a rising incidence globally and in Hong Kong, an area where chronic hepatitis B (CHB) remains endemic. IBD patients are usually immunocompromised due to the disease itself and secondary to the use of medications including immunosuppressants and biologics, predisposing them to various opportunistic infection including hepatitis. Vaccination against hepatitis B virus (HBV) is recommended to prevent CHB and its related complications including flare up of acute hepatitis, cirrhosis and hepatocellular carcinoma. However, it is reported that efficacy with conventional intramuscular hepatitis B vaccination in IBD patients is suboptimal, especially among those receiving biologic therapies. Various strategies in boosting vaccine immunogenicity including the utilization of higher vaccination dose, shorter dosing interval, or alternate route of vaccine administration have been studied.6 Intradermal route of vaccination has been recently shown to be an effective way in augmenting immune response in specific patient groups who are known poor responders, including elderly and immunocompromised patients. In addition, topical imiquimod, a synthetic agonist of toll-like receptor 7 (TLR7), has been shown to further boost up the immunogenicity response when applied to the site before intradermal vaccination. The proposed study is the first clinical trial comparing the efficacy of intradermal hepatitis B vaccination with adjuvant topical application of imiquimod cream with the conventional intramuscular hepatitis B vaccination in IBD patients.
About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at disproportionately high risk for HCC and increased healthcare costs. Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management.