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Hepatitis B clinical trials

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NCT ID: NCT01292421 Withdrawn - Clinical trials for Healthy, no Evidence of Disease

Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination

Start date: February 2013
Phase: N/A
Study type: Interventional

RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg vaccine therapy in healthy participants who have undergone previous vaccination.

NCT ID: NCT01260610 Withdrawn - Chronic Hepatitis B Clinical Trials

Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Start date: June 2011
Phase: N/A
Study type: Interventional

Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.

NCT ID: NCT01204827 Withdrawn - Chronic Hepatitis B Clinical Trials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: 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: 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: NCT00862706 Withdrawn - Clinical trials for Compensated Chronic Hepatitis B

Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks

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

The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment

NCT ID: NCT00800787 Withdrawn - Clinical trials for Hepatitis B, Chronic

Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation

Nabi-HB-SC
Start date: April 2010
Phase: Phase 3
Study type: Interventional

A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.

NCT ID: NCT00782301 Withdrawn - Hepatitis B Clinical Trials

Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients

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

Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.

NCT ID: NCT00715715 Withdrawn - Chronic Hepatitis B Clinical Trials

Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients

Start date: April 2008
Phase: N/A
Study type: Interventional

Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. After stopping steroids, viral production usually decreases. Many studies in the past have studied taking a low dose steroid before treating hepatitis B. Those studies have shown that low dose steroids help your body to clear the virus. The goal of this study is to improve the liver function by slowing viral growth.