View clinical trials related to Hepatitis.
Filter by:Hepatitis B virus (HBV) infection is a worldwide health problem. It has been proved that the persistence of HBV is associated with the failure to stimulate an efficient HBV-specific immune response. T101, the Chinese counterpart of TG1050, is a replication-defective adenovirus serotype 5 (Ad5) expressing multiple HBV-specific antigens (core, polymerase and envelope) and is used as therapeutic vaccine for chronic hepatitis B patients. The application of T101 aims at inducing a broad HBV-specific cellular immune response and ultimately eliminating HBV infection.
The first purpose of this study is to test the body's protective reaction (making antibodies) to a licensed hepatitis B vaccine (Recombivax-HB) after it is injected either in the arm fat or muscle. Hepatitis B virus is an important cause of liver disease in humans. More than 21% of healthy adults over age 60 years demonstrate evidence of previous Hepatitis B infection using a common blood test. The second purpose of this study is to learn more information about other reasons (such as body fat content, gene types, etc.), why older people respond less well than younger people to vaccines. The Investigators will also learn more about the ability of certain white blood cells, called T cells, to respond to protein signals in the blood. T cells do not seem to respond as well to these protein signals as individuals age. The Investigators will compare results to a younger group of volunteers who have also been vaccinated with hepatitis B vaccine.
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), if left untreated it can lead to chronic liver disease, cirrhosis and cancer. HCV is a blood borne virus, the key risk group for HCV infection are those who currently inject drugs, or have done in the past. For many years the treatment of chronic HCV infection was based on therapies that had significant side effects, long treatment period and were between 50-70% effective, this impacted on patient acceptability and compliance. However, for those completing the treatment and undergoing this "personal trial" literature describes the transformative experience of HCV cure and how people took steps towards a "normal life" moving beyond substance use. Recent advances in Direct-Acting Antiviral (DAA) medicines available to cure HCV have transformed treatment with shorter treatment periods, few side effects, ease of administration and improved efficacy. However, there is a potential paradox, in that the DAA-based regimes provide a reliable cure, for a large majority of patients, with a relatively small treatment burden, but may not be a "personal trial" and may have a lesser impact on rehabilitation and recovery from substance use. The success of attempts of the group cured of HCV with DAAs, to progress down a recovery pathway and to resume activities thought of as being part of normal citizenship, are therefore unclear. This study will examine the types of activities that people cured of HCV undertake and the success of their recovery pathway, post-treatment with DAAs over a two year follow-up period.
This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.
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.
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
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.
The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection.