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Hepatitis B, Chronic clinical trials

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NCT ID: NCT02523547 Recruiting - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

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

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

NCT ID: NCT02511743 Completed - Hepatitis B Clinical Trials

Knowledge and Practice of Chinese Medical Specialists Regarding Chronic Hepatitis B Virus Infection

Start date: April 2015
Phase: N/A
Study type: Observational

The aim of this study was to evaluate knowledge and behavior of physicians regarding Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection. These results provide data support for updating guidelines, continuing training, and even developing policies in medical insurance.

NCT ID: NCT02510963 Recruiting - Clinical trials for Hepatitis B, Chronic

Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy

Start date: November 2015
Phase: N/A
Study type: Interventional

To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.

NCT ID: NCT02505009 Completed - Chronic Hepatitis B Clinical Trials

Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy

Start date: May 1, 2015
Phase: Phase 4
Study type: Interventional

Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but only about 30-40% remain sustained response 1-3 years after discontinued therapy. The investigators will try to improve the sustained response rate by given a course of HBV vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir therapy. Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are suppressed during entecavir or tenofovir therapy. Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30 months will be invited to this study. The case group will receive 5 Engerix-B injections during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group: 75 cases will be enrolled to receive Engerix-B injection and compared with histological non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be randomized into case (vaccine) and control group according to age, gender, pretreatment HBV DNA level. Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be discontinued after completed therapy. Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy. Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL after discontinued nucleos(t)ide analogues therapy will be considered to have sustained response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously without further therapy will be defined as delayed response. Patients with persistent HBV DNA greater than 1*100000 cps/mL will be considered to have non-sustained response. Study duration: The enrollment will be completed in one year and keep on observation for additional 2 years. Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may decrease the HBV relapse rate at 1 and 2 year after completed therapy.

NCT ID: NCT02499562 Completed - Clinical trials for Hepatitis B, Chronic

A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

HBV
Start date: June 25, 2015
Phase: Phase 2
Study type: Interventional

To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

NCT ID: NCT02498275 Terminated - Clinical trials for Hepatitis B, Chronic

Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients

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

This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.

NCT ID: NCT02482272 Recruiting - Clinical trials for Hepatitis B, Chronic

Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

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

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

NCT ID: NCT02479880 Terminated - Hepatitis B Clinical Trials

Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

Start date: July 3, 2015
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.

NCT ID: NCT02476695 Recruiting - Cirrhosis Clinical Trials

FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

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

This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference. Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.

NCT ID: NCT02474316 Recruiting - Chronic Hepatitis B Clinical Trials

Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients

Start date: August 2014
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks