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Hepatitis B clinical trials

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NCT ID: NCT01863589 Completed - Hepatitis B Clinical Trials

Drug Use Investigation for HEPSERA (Adefovir) Tablet

Start date: February 2005
Phase: N/A
Study type: Observational

This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.

NCT ID: NCT01861613 Completed - Hepatitis B Clinical Trials

Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

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

At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.

NCT ID: NCT01856413 Completed - Hepatitis B Clinical Trials

A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant

ZEUS
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection. Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection. Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting. Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks. During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

NCT ID: NCT01855997 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

Start date: August 2013
Phase: N/A
Study type: Observational

This phase 4 study is designed for the collection of blood biomarker samples from patients who have completed chronic hepatitis B treatment with at least 25 weeks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood DNA samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for patients who previously have consented and donated RCR DNA samples) and medical record capture.

NCT ID: NCT01847430 Completed - Hepatitis B Clinical Trials

Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder

Start date: July 19, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.

NCT ID: NCT01844414 Completed - HIV Clinical Trials

UCLA-Amity Parolee Health Promotion Study

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

The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.

NCT ID: NCT01826760 Completed - Clinical trials for Acute-on-chronic Hepatitis B Liver Failure

Study of the Model to Predict 3-month Mortality Risk of Acute-on-chronic Hepatitis B Liver Failure

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

This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system. The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN and MELD-based scoring systems to evaluate the performances of the ANN prediction.

NCT ID: NCT01821547 Completed - Hepatitis B Clinical Trials

New Methods to Measure the Immune Response to Hepatitis B Vaccine

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.

NCT ID: NCT01813487 Completed - Chronic Hepatitis B Clinical Trials

Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

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

The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.

NCT ID: NCT01810835 Completed - Hepatitis B Clinical Trials

Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.

Start date: November 2011
Phase: N/A
Study type: Observational

The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.