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Hepatitis B clinical trials

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NCT ID: NCT00289770 Completed - Hepatitis B Clinical Trials

Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

Start date: November 1, 2004
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. This protocol posting deals with objectives & outcome measures of the extension phase at Year 11-15.

NCT ID: NCT00289744 Completed - Hepatitis B Clinical Trials

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

Start date: February 16, 2004
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00289731 Completed - Hepatitis B Clinical Trials

Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

Start date: November 24, 2003
Phase: Phase 4
Study type: Interventional

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00289718 Completed - Hepatitis B Clinical Trials

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

Start date: November 1, 2004
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.

NCT ID: NCT00277576 Completed - Chronic Hepatitis B Clinical Trials

Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection

Start date: January 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to reduce hepatitis B disease.

NCT ID: NCT00275938 Completed - Chronic Hepatitis B Clinical Trials

Interferon Alpha 2b Plus Ribavirin for Chronic Hepatitis B

Start date: October 1998
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B virus (HBV) causes a wide spectrum of liver diseases, such as fulminant or acute hepatitis, chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. The number of individuals infected with this virus has been estimated to be as high as 350 million. Thus, in addition to global hepatitis B vaccination, effective treatment of chronic hepatitis B is also needed. Currently, there are no effective antiviral treatments to cure HBV infection in patients with chronic hepatitis B. Five drugs have been approved for the treatment of chronic hepatitis B at present: conventional interferon (IFN) alpha, lamivudine, adefovir dipivoxil, pegylated IFN alpha and recently entecavir. Overall, satisfactory virologic and serologic responses could be achieved using pegylated IFN alpha alone in around 20-44% of these patients. Nevertheless, better treatment options are still needed for the remaining >50% non-responders. Although the best treatment choice for chronic hepatitis B is not clarified yet, certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C. A major advancement in treating hepatitis C virus (HCV) infection has been the development of combination therapy with IFN and ribavirin. IFN monotherapy is limited by poor sustained virologic responses, even when higher doses of IFN are used. IFN plus ribavirin combination therapy, in contrast, results in much improved treatment outcomes. In our previous study and others, sustained remission rate after cessation of therapy were significantly higher in patients receiving combination therapy than those receiving IFN alone. Therefore, combination therapy with IFN and ribavirin has been recommended as the standard treatment regimen for chronic hepatitis C. Furthermore, we have used ribavirin and IFN combination for the treatment of dual chronic hepatitis B and C, and the results also revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV infection. Interestingly, after a little more than 2-year post-treatment follow-up, we found that a significant portion (21%) of the responsive patients also cleared HBsAg. These findings imply that this combination regimen might be also effective for the control of chronic hepatitis B. We thus conducted a randomized, multi-center, placebo-controlled study in patients with HBeAg-positive chronic hepatitis B.

NCT ID: NCT00275652 Completed - Hepatitis B Clinical Trials

A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.

Start date: June 2004
Phase: Phase 3
Study type: Interventional

This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and effective in the treatment of hepatitis B infection. In addition to this, we will be looking at the comparison of the effects (good and bad) of LdT and lamivudine.

NCT ID: NCT00272493 Completed - HIV Infections Clinical Trials

Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals

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

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance that is made by the body in response to infection or inflammation, and greatly improves cellular immune responses. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus (HBV) vaccination in HIV infected individuals.

NCT ID: NCT00263614 Completed - Chronic Hepatitis B Clinical Trials

Evaluation of Chronic HBV Patients w/Evidence of HBV Replication and Normal or Minimally Elevated Liver Transaminases.

Start date: December 2005
Phase: Phase 4
Study type: Observational

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.

NCT ID: NCT00244374 Completed - Hepatitis C Clinical Trials

A Randomized Trial of Vaccine Adherence in Young Injection Drug Users

UFO VAX
Start date: August 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects of (a) immunization setting and (b) outreach worker support on young injection drug users' (IDU) adherence to a multiple dose immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B virus (HBV) recombinant vaccine.