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Hepatitis B clinical trials

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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.

NCT ID: NCT02850848 Completed - Hepatitis B Clinical Trials

Pharmacokinetics of Two Formulations of Entecavir

Start date: December 2015
Phase: Phase 4
Study type: Interventional

A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy

NCT ID: NCT02849132 Active, not recruiting - Hepatitis B Clinical Trials

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.

NCT ID: NCT02845401 Active, not recruiting - Clinical trials for Chronic Hepatitis B Virus

The Hepatitis B e-Antigen Negative Disease - Directly Offered Study of Treatment Withdrawal in Patients With e-Antigen Negative Chronic HBV Infection (BeNEG-DO).

BeNEG-DO
Start date: November 17, 2016
Phase: N/A
Study type: Interventional

The investigators' research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in developed countries is treated indefinitely with antiviral drugs. The investigators' study "BeNEG-DO," directly offers patients who are already taking standard oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or continue treatment. Drawing on data from pilot studies, including the investigators' own University of California, San Francisco and Sutter Institutional Review Board-approved study, the investigators will examine a finite HBV treatment strategy on clinical outcome and safety. In conjunction, the investigators will study immunologic mechanisms and gene expression profiles that correlate with and predict the post-treatment clinical course. The BeNEG-DO study could seriously question, and potentially change, the current treatment paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral therapeutics.

NCT ID: NCT02838810 Recruiting - Chronic Hepatitis B Clinical Trials

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

Start date: June 2016
Phase: Phase 4
Study type: Interventional

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

NCT ID: NCT02836249 Completed - HBV Clinical Trials

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)

Start date: June 19, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.

NCT ID: NCT02836236 Completed - HBV Clinical Trials

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

Start date: June 19, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection in China.

NCT ID: NCT02826070 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

EFFORT Further Extension Study

Start date: April 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.