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Hepatitis B, Chronic clinical trials

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NCT ID: NCT04008004 Completed - Clinical trials for Chronic HBV Infection

A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

Start date: June 26, 2019
Phase: Phase 1
Study type: Interventional

Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection

NCT ID: NCT03982186 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

REEF-1
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

NCT ID: NCT03977857 Completed - Clinical trials for Hepatitis B, Chronic

Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic

Start date: March 1, 2019
Phase:
Study type: Observational

HBV-related acute-on-chronic liver failure (HBV-ACLF) deteriorates rapidly with a high short-term mortality. Early identification and accurate prognostic prediction was critical to improve survival rate. This study was sought to determine the liver volumetry as predictor for short-term mortality in HBV-ACLF and develop a simpler prognostic model based on liver morphology. Liver volumetry were determined from CT at admission. Univariate and multivariate logistic regression were used to identify the optimum prognostic indicators and develop prognostic model. Additionally, receiver operating characteristic curves were analyzed to evaluate the predictive ability of the model.

NCT ID: NCT03933384 Recruiting - Hepatitis B Clinical Trials

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Start date: August 19, 2019
Phase: Phase 4
Study type: Interventional

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

NCT ID: NCT03932513 Terminated - Hepatitis B Clinical Trials

Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients

Start date: April 11, 2019
Phase: Phase 2
Study type: Interventional

A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection

NCT ID: NCT03909191 Completed - Clinical trials for Chronic HBV Infection

Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

Start date: February 1, 2016
Phase:
Study type: Observational

As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.

NCT ID: NCT03905655 Completed - Chronic Hepatitis B Clinical Trials

Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B

Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB).

NCT ID: NCT03866187 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

Start date: March 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment.

NCT ID: NCT03847246 Completed - Chronic Hepatitis b Clinical Trials

Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions.

NCT ID: NCT03801798 Active, not recruiting - Hepatitis B Clinical Trials

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Start date: February 11, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B