Clinical Trials Logo

Hepatitis B Infection clinical trials

View clinical trials related to Hepatitis B Infection.

Filter by:
  • Completed  
  • Page 1

NCT ID: NCT03627507 Completed - Clinical trials for Hepatitis B Infection

Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.

Start date: July 29, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B is a common and serious infectious disease of the liver, affecting millions of people throughout the world. Persistent Hepatitis B virus infections may cause development of chronic hepatic insufficiency, cirrhosis and hepatocellular carcinoma. Adding to that, Hepatitis B Virus carriers can transmit the disease for many years. It is transmitted through blood or other body fluids infected with the Hepatitis B virus. It is a major cause of morbidity and mortality in countries like Bangladesh. Immunization with Hepatitis B vaccine has been proved effective to prevent HBV infection. But the vaccines, which are recommended till now, are expensive. Locally manufactured Hepatitis B vaccine will be safe, cost effective and affordable for all. The test vaccine will induce similar seroprotection rates to hepatitis B one month post-vaccination and at 7 months, one month after the third dose of vaccine compared to reference vaccine. This will be done by comparing the percentages of participants with ≥10 mIU/ml anti-HBs by vaccinated with either Hepa B or Engerix B vaccine. The non-inferiority margin will be 10%.

NCT ID: NCT02443233 Completed - Clinical trials for Hepatitis B Infection

Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong

Start date: January 2014
Phase: N/A
Study type: Observational

Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis. There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to answer the following questions: 1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure 2. the prevalence of immunoprophylaxis failure in Hong Kong

NCT ID: NCT02304315 Completed - Clinical trials for Hepatitis B Infection

A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

Start date: February 2015
Phase: Phase 2
Study type: Interventional

This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

NCT ID: NCT01970254 Completed - Cancer Clinical Trials

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy

Start date: June 24, 2013
Phase:
Study type: Observational

This trial studies hepatitis B screening strategies of new cancer patients scheduled to undergo chemotherapy. Patients with cancer and hepatitis B virus infection are at risk of reactivation of infection after chemotherapy. Hepatitis B virus infection reactivation can be prevented by starting antivirals before chemotherapy in patients who are hepatitis B virus infection positive. Hepatitis B screening may help doctors prevent the reactivation of hepatitis B virus infection after chemotherapy.

NCT ID: NCT01788371 Completed - Clinical trials for Hepatitis B Infection

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

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

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

NCT ID: NCT01488526 Completed - Clinical trials for Hepatitis B Infection

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Start date: March 1, 2012
Phase: Phase 4
Study type: Interventional

Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients. Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: 1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL (or > 200,000 IU/mL) during late pregnancy and infants. 2. Its efficacy in the reduction of HBV vertical transmission rate.

NCT ID: NCT00841477 Completed - HIV Infection Clinical Trials

An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

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

The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-treatment drug users. This study will also examine the effect of HBV vaccination coupled with community-based outreach intervention on reducing the incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk behaviors related to these viral transmissions. A secondary purpose will be to assess the antibody response after HBV vaccination as a measurement of immunological response in drug users.

NCT ID: NCT00489099 Completed - Clinical trials for Hepatitis B Infection

A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Start date: June 2005
Phase: Phase 3
Study type: Interventional

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

NCT ID: NCT00371150 Completed - Clinical trials for Hepatitis B Infection

Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection

Start date: November 2006
Phase: Phase 4
Study type: Interventional

The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.