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Hepatitis B clinical trials

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NCT ID: NCT02594293 Completed - Chronic Hepatitis B Clinical Trials

Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy

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

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.

NCT ID: NCT02589652 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

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

This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.

NCT ID: NCT02589457 Completed - Chronic Hepatitis B Clinical Trials

Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.

NCT ID: NCT02588937 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

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

The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.

NCT ID: NCT02584543 Completed - Hepatitis B Clinical Trials

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)

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

This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6. Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.

NCT ID: NCT02582333 Completed - Prognosis Clinical Trials

Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy

Start date: October 1, 2015
Phase:
Study type: Observational

Background: Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future. Objectives: 1. To access the clinical and virological changes after stopping NA therapy 2. To determine important prognostic indicators for stopping NA therapy Methods: In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data: 1. Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history. 2. Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.

NCT ID: NCT02581033 Recruiting - Clinical trials for Chronic Hepatitis B.

Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in Hepatitis B Patients

STOP
Start date: May 2014
Phase: N/A
Study type: Interventional

Evaluation of the rate of sustained virological response among HBeAg-negativechronic hepatitis B patients who discontinue long-term NA therapy. During this study participants will cease their prescribed medications, this will occur with immediate effect once enrolled into the study. The duration of cessation will be indefinite, unless clinically indicated for NA therapy re-start. Participants will be monitored as per protocol following cessation, monitoring will be by clinic visit and through blood test to monitor virological response. Clinical visits will be at the intervals of week 2, week, 4, week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the participant will have completed the trial. Once the participant has completed the trial they will not commence again, the aim is for an indefinite cessation of NA therapy.

NCT ID: NCT02579382 Completed - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

Start date: November 10, 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

NCT ID: NCT02577029 Terminated - Hepatitis B Clinical Trials

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

MONARCH
Start date: December 2015
Phase: Phase 2
Study type: Interventional

Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.

NCT ID: NCT02570191 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.