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Hepatitis clinical trials

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NCT ID: NCT01204827 Withdrawn - Chronic Hepatitis B Clinical Trials

Follow Up of Patients Chronic Hepatitis B (CHB) Treated With Sebivo Using the 13C Methacetin Breath Test

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes. However these do not always reflect the degree of liver impairment or the degree of improvement in response to therapy. Sebivo has been accepted in Israel as a first line therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage. Viral load should decrease by 1 log every 3 months, otherwise patients should be offered add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative chronic HBV and in order to have homogenous population we will select for our study only patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver function and specifically the function of the microsomal CYP4501A2. It has been shown to correlate with the degree of liver impairment and with clinical outcomes in both acute and chronic liver disease. The aim of this study is to determine the utility of the 13C Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti viral therapy.

NCT ID: NCT01179594 Withdrawn - Clinical trials for Hepatitis B, Chronic

A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

Start date: September 18, 2010
Phase: Phase 4
Study type: Interventional

This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.

NCT ID: NCT01157975 Withdrawn - Hepatitis C Clinical Trials

Study the Relationship Between Obesity and Hepatitis C Replication

Start date: October 2008
Phase: Phase 2
Study type: Interventional

Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems. PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .

NCT ID: NCT01142700 Withdrawn - Clinical trials for Chronic Hepatitis C Virus Genotype 1

A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

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

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.

NCT ID: NCT01126853 Withdrawn - Hepatitis B Clinical Trials

Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders

Start date: April 2010
Phase: Phase 4
Study type: Interventional

Hepatitis B is a vaccine preventable infection which can be transmitted through occupational exposure. Approximately 15% of patients will not respond to an initial series of vaccination. Of those re-vaccinated approximately fifty percent will respond. On the basis of poor response to a third series, repeat vaccination is not recommended and non-responders are considered vulnerable to infection. Cardell studied the use of double dose combination hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses previously and found a high response rate suggesting this vaccine and dose could be effective. The investigators study seeks to duplicate the findings of Cardell, using a more strict definition of non-responder (6 or more previous doses).

NCT ID: NCT01062659 Withdrawn - Clinical trials for Hepatitis C, Chronic

Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients

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

In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.

NCT ID: NCT00986778 Withdrawn - Clinical trials for Hepatitis B, Chronic

Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

NCT ID: NCT00976781 Withdrawn - Hepatitis C Clinical Trials

Identifying the Gaps in the Diagnosis and Management of Hepatitis C

Start date: August 2008
Phase:
Study type: Observational

The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C infected patients so that interventions can be targeted to address these problem areas in order to optimize care of these patients.

NCT ID: NCT00951223 Withdrawn - Hepatitis C Clinical Trials

Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C

REACHSVR
Start date: August 2009
Phase: N/A
Study type: Observational

This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.

NCT ID: NCT00930995 Withdrawn - Hepatitis C Clinical Trials

Angiotensin Receptor Blockade as an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C

Start date: n/a
Phase: Phase 2
Study type: Interventional

Hepatitis C is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Morbidity and mortality from hepatitis C are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. Efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions. Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. Thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis C.