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Hepatitis B clinical trials

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NCT ID: NCT02901951 Completed - Hepatitis B Vaccine Clinical Trials

Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B

Start date: October 11, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the long-term protection against HBV infection in adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30 years ago

NCT ID: NCT02898922 Completed - Clinical trials for Hepatitis B Vaccines

Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C:An Open-label Control Study in China

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

Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV) can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection. Whether patients with HCV infection have non-protective antibody responses to hepatitis B vaccination more frequently than healthy subjects is still controversial and studies about cytokine response have been seldom reported. Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender matched healthy control were obtained from a community-based screening. All participants received three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months schedule. Anti-HBs was tested 1 month after the third dose of vaccination and was compared between two groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.

NCT ID: NCT02888106 Completed - Clinical trials for Chronic Viral Hepatitis B With Delta-agent

Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent

NCT ID: NCT02881008 Completed - Chronic Hepatitis B Clinical Trials

Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

Start date: November 14, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.

NCT ID: NCT02877589 Completed - Solid Tumor Clinical Trials

Interest of Routine Screening for Hepatitis B and C in Patients Receiving Chemotherapy for Solid Tumors

HepScreen
Start date: May 2012
Phase: N/A
Study type: Observational

Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but can cause fulminant hepatitis and death. More, they impact the treatment of cancer by chemotherapy delays or stops. They can occur during cancer treatment but also after stopping, at the immunological rebound. This risk persists for at least 6 months after cessation. The key to the prevention, and the first step, is serological testing. It is also the main problem because international recommendations diverge. Hepatologists and infectious disease specialists recommend routine screening HBV of all candidates for immunosuppressive therapy. These recommendations are more implemented by hematologists, given the frequency of HBV reactivation associated to haematological malignancies. Clinical oncology societies guidelines suggest a selective screening in case of risk factors of hepatitis B or in patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell transplantation or lymphoma treatment). The consequence of these differences is a sub-screening by oncologists and the persistence of fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV and HCV can be assessed.

NCT ID: NCT02876419 Completed - Clinical trials for Hepatitis B, Chronic

A Long Term Follow-up Study of Patients From the REP 301 Protocol

Start date: August 2016
Phase:
Study type: Observational

The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

NCT ID: NCT02862548 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

Start date: September 16, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.

NCT ID: NCT02862106 Completed - Chronic Hepatitis B Clinical Trials

Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

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

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

NCT ID: NCT02858440 Completed - Hepatitis B Clinical Trials

A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia

Start date: September 13, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule

NCT ID: NCT02853929 Completed - Hepatitis B Clinical Trials

Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

Start date: September 19, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.