Active clinical trials for "Hepatitis"

Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients. Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL (or > 200,000 IU/mL) during late pregnancy and infants. Its efficacy in the reduction of HBV vertical transmission rate.

This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.

Background: In patients with chronic HCV-related liver damage, coffee is associated with a reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This prospective trial is aimed at assessing the mechanisms underlying the protective effect of coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with HCV-related hepatitis will be recruited and randomized into two groups: the first will consume 4 coffee cups/day/1 month, while the second will remain coffee "abstinent". At day 30, the two groups will be switched over and exposed to coffee or not for a second month. Before entering the study (time 0), during coffee exposure and during abstinence we will evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.

Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco. The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis. Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.

A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.

Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a commonly prescribed component of highly active antiretroviral therapy(HAART) in developing countries. This clinical trials is designed to determine the efficacy and the cost-effectiveness of this approach in the developing countries setting. NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national universal health coverage. Information of the prescribed drug will be collected, and monitoring for the compliance with the prescribed highly active antiretroviral therapy will be conducted. Outcome measurements: The primary objective of this study is to evaluate the reduction in incidences of NVP associated cutaneous side effects by genotype based personalized prescription. The volunteers will be monitored for any solicited and non-solicited adverse effects for 6 months after drug administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions. Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin, lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring period (6 weeks). Statistical Methods: Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables will include overall follow-up rate, drug compliance, and events of protocol violation. Laboratory and safety data will be presented using comparative statistics for each study group and compared within and between groups using standard parametric or non-parametric comparison tests, i.e., McNemar's test or paired t-test as appropriate. Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse reaction(SCAR) will be made with chi-square test. Variable that shown significant different between the "standard of care" or control group and the "genetic test" or intervention group will adjusted for the final analysis with Poisson logistic regression. The overall rate of adverse events in all participants will be monitored whether the rate of adverse events is lower than the predefined criteria. The extension of trial may be considered based on the rate of adverse events.

HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region). The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies. The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut.

The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans.

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary