View clinical trials related to Hepatitis.
Filter by:This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.
Background: - 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.
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.
Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in such circumstance according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM, studies on the proper prophylactic antiviral regimen is warranted. The present multicenter, prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.
The purpose of the study is to 1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.