View clinical trials related to Hepatitis.
Filter by: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.
This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.
A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).
The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment. Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment. In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%. In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks. In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.
This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by ELISA and mRNA expression by real-time PCR with histopathological hepatic biopsy findings in individuals with HIV/HCV coinfection. This population will be divided into three groups (G1: with no HAART; G2: with detected HIV viral load (HIV VL); G3: with undetected HIV VL), which will be then compared to two control groups with monoinfection by HIV or by HCV, in addition to a third control group comprising normal blood donors.
1. Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection. 2. Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.
Open-label studies, anecdotal reports, and in vitro scientific research indicate that 4-methylumbelliferone (active ingredient of the dietary supplement Heparvit®) may prevent and reverse the symptoms and complications of chronic infection with hepatitis B virus (HBV)and hepatitis C virus (HCV). This effect has been observed among naïve patients as well as those who are non-responders to interferon, commonly used as first-line therapy for HBV and HCV. In order to scientifically address the efficacy of this 4-methylumbelliferone on chronic viral hepatitis, a randomized, placebo-controlled, blinded study is needed. It is hypothesized that 4-methylumbelliferone may reduce the impact and aggressiveness of HBV and HCV upon the liver, thereby slowing the progression to potentially life threatening liver diseases such as cancer and cirrhosis. This is a preliminary study designed to determine any indications under controlled conditions that may warrant further detailed clinical studies.
Objectives: Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic response following previous interferon therapy. Secondary - To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values. - To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4, 12, and 24 as compared to baseline. - To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values. - To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy. - To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease. Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: - 800 mg (400 mg bid) if body weight < 65 kg - 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg - 1200 mg (600 mg bid) if body weight > 85 kg Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks. - Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks. - Group B: No CHC therapy for 72 weeks All patients entering the study are required to have a baseline liver biopsy (within 18 months of study entry). Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial. Study Population: 100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy. Dosage and Administration: Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: - 800 mg (400 mg bid) if body weight < 65 kg - 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg - 1200 mg (600 mg bid) if body weight > 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly. Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2a and Ribavirin dosages will be obtained. Safety Evaluations: - Assessment of laboratory evaluations - vital signs - incidence and severity of adverse experiences - dose adjustments - premature withdrawal for safety reasons - progression of disease as measured by HCV viral load - AIDS defining events
Re-infection of the liver graft occurs universally following liver transplantation for HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is extremely variable from one patient to another. The host and viral factors being responsible for the different course of HCV infection are poorly understood. Our study will focus on dendritic cells which are known to play a critical role in the control of viral infection. Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients transplanted for HCV-related disease and 10 controls transplanted for non HCV-related disease. Blood samples will be taken just before transplantation and at different time -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be enumerated. HCV quasispecies evolution will be analysed. This study may help to define prognostic markers on progression of hepatitis C in liver transplantation and allow the development of new immunotherapeutic drugs
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.