Active clinical trials for "Hepatitis"

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

This is a single-arm study. Key eligibility criteria include (1) newly diagnosed, diffuse large B-cell or follicular cell non-Hodgkin's lymphoma; (2) negative test for hepatitis B surface antigen (HBsAg) and positive for antibody to hepatitis B core antigen (anti-HBc); (3) adequate bone marrow, liver, and kidney function. All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines. The primary endpoint of this study is the incidence of hepatitis B virus (HBV) reactivation, defined by a greater than 10-fold increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy and within 1 year after completion of the last course of rituximab-CHOP chemotherapy. Patients who have HBV reactivation during the study period will receive free entecavir treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks. The secondary endpoints include the incidence of hepatitis flare, defined as a greater than 3 fold increase of serum alanine aminotransferase (ALT) level that exceeded 100 IU/L, and the efficacy and safety of rituximab-CHOP chemotherapy. In the T1408 study we enrolled patients with newly diagnosed lymphoma who were HBsAg (-) and anti-HBc (+) and were to receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone)-based chemotherapy. Key findings of this study included (1) HBV reactivation, defined as a greater than 10-fold increase in HBV DNA compared with previous nadir levels, occurred to 10-20% of patients, depending on the sensitivity of the HBV DNA tests; (2) no HBV-related death with the prompt anti-viral therapy upon HBV reactivation; (3) patients with HBV reactivation were associated with poorer progression-free survival and overall survival; (4) serological breakthrough (i.e., re-appearance of HBsAg) is an important predictor of HBV-related hepatitis flare. In this amendment we will enroll more patients to clarify the above findings: (1) the association between HBV reactivation and survival; (2) diagnostic value of quantitative HBsAg and anti HBc tests on HBV reactivation; (3) whether host factors (DNA polymorphism) may help predict HBV reactivation. A larger patient cohort is needed to identify (1) baseline features that may help predict HBV reactivation, and (2) on-treatment features that may help timely anti-viral therapy.

The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).

The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. This is an observational study without study specific interventions.

The investigators hypothesize that a well-designed hepatitis C (HCV) video education curriculum for active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. The investigators will use a short 10 minute video designed for active drug users to and assess its impact vs. a usual-care counseling intervention. The investigators will measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after intervention.

Taiwan is an endemic region for hepatitis B. Before the implementation of a nationwide vaccination program in 1984, the hepatitis B virus (HBV) carrier rate in the general population was 15 to 20%.1-2 The major impact of hepatitis B (HB) infection is its long-term sequelae which may include chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma.3 Perinatal infection accounts for 40-50% of all hepatitis B infections and is responsible for the generation-to-generation transmission of HB virus.4 Hepatitis B vaccines, both plasma derived and recombinant, are highly immunogenic and efficacious.5-10 It has been reported that HB vaccine given soon after birth is able to protect infants from perinatal infection and HB infection became the first disease model to show that mother-to-neonate transmission can be interrupted by an effective vaccine.11 Taiwan started a national program of HB vaccination since 1984. This program resulted in a significant reduction of the HB carrier rate in children aged below 10 years from 9.8% before nationwide vaccination to 1.3% after the program.12 It also decreased the incidence of hepatocellular carcinoma in children aged 6 to 9 years from 0.52 to 0.13 per 100,000.13 However, the duration of protection provided by the HB vaccine and the proper timing of a booster dose remains unclear. Because the HB vaccine is a subunit protein vaccine, which contains only HBsAg, a limited duration of protection is anticipated. The results of several long-term follow-up studies of the protective efficacy of HB vaccination have been published. Soon after vaccination, protective levels of antibody (anti-HBs >10 mIU/mL) can be detected in the great majority (83-99%) of vaccinees.5-7 The proportion of vaccinees with protective anti-HBs levels decreases to 75-87% 5 years after vaccination and further drops to 50 to 70% 10-12 years after.10,11,14,15,19-21 Because of the progressive decline of anti-HBs and the associated increased likelihood of development of new HBV infections, some investigators advise the use of a booster vaccination.20,21 However, a preponderance of data indicates that the protective efficacy of the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not necessary.16-18,22,23 By demonstrating significant augmentation of cellular immunity and adequate induction of a protective level of antiHBs (>10 mIU/ml) in HBsAg and HBeAg-positive subjects 10 years after HB vaccination, we also proved that protection afforded by HB vaccination persisted for no less than 10 years in all vaccinees.R Nevertheless, the protective efficacy after the period of 10 years remains unknown. Knowledge of the duration of protection of HB vaccine and the optimal timing of booster vaccination remains crucial. In this study, we are going to examine the humoral and cellular immunity and monitored the antibody response following a booster dose of HB vaccine in a group of children whom had been vaccinated 14 years prior to this study.

The purpose of this study is to find if the Single Photon Emission Computed Tomography (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV). A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT scan, which takes a picture of the liver, has been found to be effective in determining liver damage but studies need to be done in patients with hepatitis. This study will compare the effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is found to be as good as or better than liver biopsies.

The purpose of this study is to find out how many children who are infected with HIV are also infected with hepatitis C virus (HCV). HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV appear to have more rapid HIV disease progression. There is little data on how widespread HCV is among children who are HIV-infected. Information from this study will help determine the need for future HCV studies. This study also will obtain blood samples for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).

To define the natural history, immunologic, and genetic factors that influence the clinical outcome of hepatitis C in a cohort of hemophilic siblings.