Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol...
Hepatitis CChronic1 moreThe objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine...
DiphtheriaTetanus3 moreA randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
Pioglitazone on Viral Kinetics, Cytokines and Innate Immunity in Insulin Resistant CHC GT 1 Subjects...
Chronic Hepatitis CThe purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.
A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
CarcinomaHepatocellular9 moreBackground: Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States. More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives: To identify genetic factors that may help to explain the aggressiveness of liver cancer. To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility: Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C. Participants will reside in Baltimore City and the surrounding areas. Design: Participants will complete a questionnaire and provide blood and urine samples for testing: The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer. Blood and urine samples will be collected from all participants after the questionnaire. Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease. No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.
Hepatitis A Vaccination in the Elderly
Hepatitis AA lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available. Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls. Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28. Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.
Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
Chronic Hepatitis B e Antigen PositiveChronic Hepatitis B e Antigen NegativeBackground: - Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But the drugs have not yet been approved for long-term use because some of them can have serious side effects. However, stopping treatment too soon can make the infection worse and may lead to more serious forms of liver disease. Researchers have not been able to determine a when to stop treatment. They want to study people with chronic hepatitis B infection to find out the best time to stop treatment and prevent the disease from causing further liver damage. Objectives: To study the safety and effectiveness of withdrawing antiviral treatment for chronic hepatitis B after at least 4 years of treatment. To determine whether stopping long-term antiviral treatment for chronic hepatitis B makes the infection worse. Eligibility: - People who are at least 18 years of age; have been taking antiviral drugs to treat chronic hepatitis B for at least 4 years; and are being evaluated to stop treatment. Design: Those in the study will be screened with a physical exam, medical history, questionnaire, and blood tests. They will remain under the care of their regular doctor during the study. They will have an abdominal ultrasound to study scarring in the liver, if they have not had one in the past year. Those without detectable levels of the hepatitis B virus in their blood will stop antiviral treatment. They will have monthly blood tests for the first 6 months to check virus levels, and then every 3 months afterward. Those whose blood tests show an increase in virus levels will restart antiviral treatment as directed by the study doctors and their personal doctor. All those in the study will be monitored until the end of the study.
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
Hepatitis BThis registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV
Hepatitis C Virus InfectionThe treatment of HCV-infected IDUs presents multiple challenges, such as adherence to therapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Some guidelines recommended that IDUs not be offered HCV treatment until they had stopped all such use for > 6 months, raising some questions about fairness and discrimination. Little published data exist on HCV therapy in active IDUs. However, extensive evidence exists that, when specific programs are developed, IDUs can be successfully engaged in care. In IDUs, strategies shown to improve adherence include directly-observed therapy (DOT), cash incentives, and comprehensive case management. Weekly interferon dosing now provides a means of improving HCV treatment adherence, and makes a DOT approach more practical. Within an observational, prospective clinical cohort, we will be able to identify a group of IDUs infected with HCV genotype 2 or 3 who would most benefit from treatment for their infection. We will design a systematic approach to the determination of their appropriateness for treatment, refine the approach to their treatment within a directly observed therapy (DOT) setting, and evaluate the success of the approach (defined as the achievement of Sustained Virologic Response (SVR)). Taken together, this project will help define a systematic approach to HCV infection in the inner city. The hypothesis is that the development of a systematic approach for the diagnosis of HCV and the establishment of a directly observed therapy (DOT) program for the treatment of HCV infection in IDUs will constitute an effective means of controlling the epidemic of this infection within this population.
A Video-Based HCV Curriculum for Drug Users
Hepatitis COpiate DependenceThe investigators hypothesize that a well-designed hepatitis C (HCV)video education curriculum for high-risk drug users will show measurable benefits in improving HCV testing, hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward transmission behavior change. The investigators will use a 4-part modular video series designed for at-risk drug users, and in this 12 week study will assess its impact on testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained drug users as compared to a usual-care intervention.
Neutrophil Function During Therapy With Protease Inhibitors in Chronic Hepatitis C
Chronic Hepatitis CThe aim of this study is to characterize neutrophil function in patients undergoing chronic hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.