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Hepatitis B clinical trials

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NCT ID: NCT04501224 Recruiting - Chronic Hepatitis b Clinical Trials

The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.

NCT ID: NCT04499443 Recruiting - Hepatitis B Clinical Trials

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

NCT ID: NCT04496882 Recruiting - Chronic Hepatitis b Clinical Trials

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue

CHANGE
Start date: September 9, 2020
Phase: Phase 4
Study type: Interventional

We will conduct a phase 4, multicenter, open-label trial at 7 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 2 years, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF. The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.

NCT ID: NCT04442841 Recruiting - Clinical trials for Hepatitis B Reactivation

HBV Vaccine in Anti-core Positive Donors After LT

Start date: September 2020
Phase: Phase 2
Study type: Interventional

Anti-HBc positive liver donors frequently have occult HBV infection, and several studies in HBsAg-negative subjects have shown that there is often the detection in the liver of covalently closed circular DNA (cccDNA). In the setting of liver transplantation and immunosuppresion, grafts from antiHBc positive donors may cause de novo HBV infection (defined by the development of positive HBsAg and/or detectable serum or liver HBV DNA in previously HBsAg recipients). Active immunization may be successful in up to 20% of patients who received an anti-HBc+ liver during transplantation after the first vaccination schedule, and up to 30% after a second vaccination course. Responders to vaccination could safely halt nucleos(t)ide analog prophylactic therapy with no risk of HBV reactivation during follow-up. We also hypothesize that an impaired antigen-specific adaptive cell-mediated immunity at baseline explain the lack of response Primary objective: 1. To investigate the efficacy of HBV vaccination in liver transplant recipients who received a liver from an anti-HBc positive donor. 2. To assess the safety of nucleos(t)ide treatment interruption in those patients achieving a response to HBV vaccination

NCT ID: NCT04431375 Recruiting - Hepatitis B Clinical Trials

Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV

Start date: June 22, 2020
Phase: N/A
Study type: Interventional

A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure. In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .

NCT ID: NCT04392700 Recruiting - Clinical trials for Hepatocellular Carcinoma Recurrent

A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection

Start date: July 25, 2019
Phase: Phase 3
Study type: Interventional

This study evaluates the addition of Tenofovir and Entecavir in the treatment of Hepatitis B-related hepatocellular carcinoma after curative resection in adults. Half of participants will receive Tenofovir disoproxil fumarate, while the other half will receive Entecavir.

NCT ID: NCT04386915 Recruiting - Hepatitis B Clinical Trials

Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets

GST-HG141
Start date: May 18, 2020
Phase: Phase 1
Study type: Interventional

To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .

NCT ID: NCT04357600 Recruiting - Liver Cirrhoses Clinical Trials

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B

Start date: May 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.

NCT ID: NCT04317248 Recruiting - Clinical trials for Hepatocellular Carcinoma

"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.

NCT ID: NCT04310787 Recruiting - Hepatitis B Clinical Trials

Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

Start date: May 15, 2020
Phase:
Study type: Observational

This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.