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Hepatitis A clinical trials

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NCT ID: NCT01200420 Completed - Hepatitis C Clinical Trials

Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

NCT ID: NCT01198860 Approved for marketing - CHRONIC HEPATITIS B Clinical Trials

Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B

HBV
Start date: n/a
Phase:
Study type: Expanded Access

Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. Has stronger effect on immune system, effective good against HBV replication. This is a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.

NCT ID: NCT01197157 Completed - Hepatitis C Clinical Trials

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients

Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype. However, this approach is not sufficient to substantially improve the sustained virologic response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum infection, recently was shown to have an unexpected antiviral activity in the HCV replicon system and in chronically infected patients. The aim of this work is to study impact of nitazoxanide therapy in addition to peginterferon/ribavirin combination on virologic responses in patients with chronic hepatitis C genotype 4. Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2 groups: Group A: comprises 100 CHC patients who will receive the standard of care treatment, peginterferon-alf 2a plus weight-based ribavirin for 48 weeks. Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of 500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks. Data will be collected and statistical analysis will be done comparing the groups regarding response to antiviral therapy. Final results will be discussed and compared to similar studies published in peer reviewed journals and international conferences.

NCT ID: NCT01195987 Recruiting - Clinical trials for Hepatitis C Patients

Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Start date: June 2010
Phase: N/A
Study type: Observational

The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

NCT ID: NCT01195181 Completed - Clinical trials for Chronic Liver Disease

Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.

Start date: September 2005
Phase: Phase 4
Study type: Interventional

Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world, being the major cause of progressive liver disease, primary hepatic cancer and liver transplantation. Today, a "curative" therapy is available, that can eradicate the viral infection and determine the regression of liver fibrosis, also in cirrhotic subjects. The current standard-of-care for HCV chronic infection is combination therapy with peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but determines several side effects, that can reduce drug tolerance and hence, patient adherence to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®, F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only a single amino acid differentiates these types of IFN, administration strategies depend on their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also bioactivity. No comparative data are available on the benefits and costs of the licensed Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if, the benefit and favourable cost-efficacy of this antiviral therapy is well established and of large consensus. Recently, the first randomized controlled mega-trial to compare antiviral therapeutic efficacy in naïve patients with HCV-genotype 1 infection during different regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV, has been published, confirming a similar efficacy, of around 40%, obtained with the three schedules evaluated. In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the Regional Health Councillorship, has led to the development of a clinical and epidemiological observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common database that, since 2003, has prospectively collected data on a cohort of more than 3000 patients with chronic HCV infection and, among them, of 506 naïve subjects that consecutively underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV. The aim of this study was to rationalize and improve the social regional health program on antiviral treatment of chronic hepatitis C by assessing the different schedules utilization of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in the real clinical practice (Project A).

NCT ID: NCT01194037 Completed - Clinical trials for Chronic Hepatitis C Infection

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

NCT ID: NCT01192698 Completed - Hepatitis C Clinical Trials

Intravenous Interferon During Liver Transplant

Start date: October 2009
Phase: N/A
Study type: Interventional

The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

NCT ID: NCT01189656 Unknown status - Clinical trials for Chronic Hepatitis B Patients With HBeAg-positive

A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B

Start date: January 2009
Phase: Phase 2
Study type: Interventional

To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.

NCT ID: NCT01188772 Completed - Hepatitis C Virus Clinical Trials

Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients

Start date: August 2010
Phase: Phase 2
Study type: Interventional

Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.

NCT ID: NCT01185860 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.