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Hepatitis A clinical trials

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NCT ID: NCT01464827 Completed - Chronic Hepatitis C Clinical Trials

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

NCT ID: NCT01464008 Completed - Chronic Hepatitis C Clinical Trials

The Predictive Value of On-treatment Virological Response for Sustained Virological Response in Chronic Hepatitis C

Start date: January 2004
Phase: N/A
Study type: Observational

The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many factors. Important patient-specific factors include, age, gender, race, body weight. Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally, important treatment-related factors include the type of interferon, dose of ribavirin and the duration and adherence to treatment. Despite the importance of patient- and virus-specific factors, the most important indicator of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels after the start of treatment. The on-treatment virological response can thus be used to predict the probability that a given patient will achieve an SVR if they remain on therapy. It can also be used to individualize the duration of treatment. In this study, treatment for patients with chronic hepatitis C was individualized on the basis of clinical characteristics and the on-treatment virological response. The aim was to investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in tailoring the duration of treatment and predicting SVR in Chinese patients with chronic hepatitis C.

NCT ID: NCT01462981 Recruiting - Hepatitis B Clinical Trials

Cohort of Hepatitis B Research of Amsterdam

COBRA
Start date: September 2011
Phase: N/A
Study type: Observational

Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus (HBV). Infection can result in an inflammation of the liver parenchyma with various clinical manifestations ranging from an asymptomatic course to jaundice. After contact with the virus the immunological response of the host determines the clinical outcome leading to either viral clearance or a chronic infection. Although several factors are responsible for the development of chronic HBV-infection, one of the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing T helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to liver failure. Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral load is a strong predictor for the development of cirrhosis, independent of hepatitis B e- antigen status and serum alanine transaminase level. It is unclear whether these results can be extrapolated to non-Asian (Caucasian and African) populations because of differences in host (HLA background) and viral (HBV genotype) factors. The aim of this study is to elucidate the question whether historic HBV viral load is associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.

NCT ID: NCT01459419 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is justified on the basis of scientific and medical reasons. There are data in multiple animal models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and induces regulatory T cells and immune-modulation as desired in clinical studies. These observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone induced the desired immune-modulation in terms of immunological markers for regulatory T cells and appropriate rises and declines in certain cytokine levels.

NCT ID: NCT01458535 Completed - Hepatitis C Virus Clinical Trials

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

Navigator
Start date: October 2011
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) when given together with ABT-267 and with and without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection.

NCT ID: NCT01457768 Completed - Clinical trials for Hepatitis C, Chronic

A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

Start date: December 19, 2011
Phase:
Study type: Observational

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

NCT ID: NCT01457755 Completed - Clinical trials for Hepatitis C, Chronic

Gilead Sustained Virologic Response (SVR) Registry

Start date: April 13, 2012
Phase:
Study type: Observational

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

NCT ID: NCT01455337 Unknown status - Alcoholic Hepatitis Clinical Trials

Short-term Survival in Patients With Severe Alcoholic Hepatitis Treated With Steroid Versus Pentoxifylline

Start date: January 2009
Phase: Phase 3
Study type: Interventional

Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease. Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate. Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve cytokine release and the perpetuation of injury by immunologic process, corticosteroid has been extensively evaluated in the treatment of alcoholic hepatitis. Although there are discrepancies in literature as several randomized trials and meta-analyses have reached contradictory results, corticosteroid for a subset of patients with severe alcoholic hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been recommended. This latter point emphasizes the important of meticulous selection to avoid the side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly selected minority group in which the inhibitory effect of corticosteroid on liver inflammation is not outweighed by side effects such as weakened defense against infection, anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal bleeding, which may be deleterious in these critically ill patients. Newer understanding of the role of the role of TNF-α expression and receptor activity in alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor, recently has been demonstrated in a randomized trial to improve survival in the therapy of severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to be related to a significant reduction in development of hepatorenal syndrome. These results are promising, and support the need to further evaluate the potential of this new therapeutic avenue. There is a need for head to head comparison of corticosteroid and pentoxifylline in severe alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone, an active form of prednisone. The aim of the present study was thus to compare the effects of pentoxifylline and prednisolone on the short-term mortality.

NCT ID: NCT01455090 Completed - Chronic Hepatitis C Clinical Trials

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

Start date: November 30, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

NCT ID: NCT01453348 Completed - Hepatitis B Clinical Trials

Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

Start date: October 2011
Phase: Phase 3
Study type: Interventional

This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.