Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
Hepatitis AThis safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug". Primary objective: To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B
Chronic Hepatitis BAccording to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea. The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea. The investigators plan to collect 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.
The Role of FGL2-FcgammaRIIB Inhibitory Pathway in Human Viral Hepatitis
Chronic Hepatitis C InfectionViral hepatitis is a serious world health problem affecting over 1 billion people worldwide. Presently the lack of highly effective treatments results in many patients requiring liver transplantation or death. The investigators have defined the role of a unique molecule FGL2 and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human hepatitis. The studies proposed in the present proposal will test the hypothesis that measuring levels of fgl2 in plasma will identify individuals that will go on to develop chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with both acute and chronic disease to develop an appropriate immune response and clear the virus. The studies will provide rationale for generation of new therapies to improve the treatment of patients with acute and chronic viral hepatitis by targeting fgl2.
Hepatitis B Research Network Adult Cohort Study
Hepatitis BThe primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.
Hepatitis B Research Network Pediatric Cohort Study (HBRN)
Hepatitis BThe purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.
Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Vaccine Response ImpairedHepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx). In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants...
Hepatitis CChronicThis prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
Notification of Donors With Positive Microbiology Markers
Human Immunodeficiency VirusHepatitis B3 moreEach year around 200 blood donors in the UK are found to be infected with blood-borne diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the notification procedures for these infections vary, their effectiveness and appropriateness have never been evaluated in a systematic study. The proposed research has been designed to assess the responses of blood donors to notification and their satisfaction with how they were informed about the infection. The study will be implemented using standard questionnaire-based measures (French et al, 2004; Marteau & Bekker, 1992). The study will involve approximately 600 blood donors who were informed of an infection or possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will be included to control for the effects of time. As the majority of donors testing positive donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the NHSBT database only, and their availability confirmed through their GP or specialist clinician. A standardized questionnaire will be then sent to all those identified as eligible. The study will last 12 months, but direct participant involvement will be limited to the time required to complete the questionnaire, which should take under one hour. To safeguard confidentiality, no identifiable personal data will be used in the analysis. Where demographic or medical information already held by NHSBT is retrieved to minimise response burden, this will be pseudonymised before use. The study is sponsored by the blood services for England, Wales, Scotland and Northern Ireland. The results will be used to inform notification procedures in the future.
History of Hepatitis C in Volunteer Blood Donors
Hepatitis CHepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers would like to study the long-term effects of this disease. Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The tests will enable researchers to provide the patients with an idea of how severe their liver disease is. The virus and patient will be studied in order to understand why patients with hepatitis C develop different levels of liver damage.
Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients
Hepatitis CThe purpose of this study is to evaluate what happens to hepatitis C virus in response to treatment with pegylated interferon and ribavirin in patients with HCV compared to those with HIV and HCV. This research is being done to help us identify how the composition of HCV changes with interferon in different populations. We will examine how quickly HCV is cleared from your body and what factors may influence that clearance. This information may help us find better treatments for HCV.