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Hepatitis B, Chronic clinical trials

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NCT ID: NCT05755776 Recruiting - Chronic Hepatitis B Clinical Trials

The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment

POWER
Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is: - The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia. - What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia. Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment. Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.

NCT ID: NCT05727267 Recruiting - Chronic Hepatitis B Clinical Trials

A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

Start date: January 23, 2024
Phase: Phase 1
Study type: Interventional

This study is an open-label, ascending dose phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine

NCT ID: NCT05721300 Recruiting - Clinical trials for Hepatocellular Carcinoma

Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer

Start date: February 10, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the outcomes of HBsAg(+) patients in the treatments of NAs vs NAs plus IFN . The main questions it aims to answer are: 1. Clinical effect analysis of nucleoside analogs (NAs) group a group and NAs plus interferon group after 48 weeks of treatment; 2. Repetitive effect and time effect of different drug treatment at different follow-up time points; 3. To evaluate the difference of therapeutic effect of NAs or NAs combined with interferon; 4. Follow up and compare the incidence of early liver cancer in each group. Participants will be asked to receive NAs or NAs combined with interferon treatments, and Regular blood sampling and color ultrasound examination. Researchers will compare control group to see if occurrence of liver cancer.

NCT ID: NCT05708560 Recruiting - Clinical trials for Hepatitis B, Chronic

Relationship Between MAFLD and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study

MAFLD-HBV 1
Start date: March 1, 2022
Phase:
Study type: Observational

This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B

NCT ID: NCT05671315 Recruiting - Chronic Hepatitis B Clinical Trials

A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients

Start date: July 3, 2019
Phase: N/A
Study type: Interventional

China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control the disease. However, studies in recent years have found that long-term therapy with Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad have shown that compared with long-term oral NAs, peginterferon can significantly reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is limit prospective studies. This multicenter, randomized, open-label, controlled trial study is aim to evaluate the pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of hepatocellular carcinoma, to provide evidences for new management and treatment strategy options for improving clinical outcomes for the chronic hepatitis B patients. About 267 chronic hepatitis patients with intermediate to high risk of liver cancer who are now receiving nucleoside therapy will be enrolled. Subjects will be randomized into the peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver cirrhosis and hepatocellular carcinoma will be assessed.

NCT ID: NCT05661786 Recruiting - Chronic Hepatitis b Clinical Trials

Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

PILOT
Start date: December 2022
Phase:
Study type: Observational

Chronic hepatitis B virus (HBV) infection remains a global public health burden around the world. Investigating the disease process of chronic hepatitis B (CHB) is essential to individual management in clinical practice. According to American Association for the Study of Liver Diseases (AASLD) 2018 Hepatitis B Guidance, CHB can be classified into four phases: immune-tolerant CHB, HBeAg-positive immune active CHB, inactive CHB and hepatitis B e antigen (HBeAg)-negative immune active CHB. Antiviral therapy is recommended in patients with HBeAg-positive or -negative immune active CHB patients to reduce the incidence of liver cirrhosis and hepatocellular carcinoma, while periodic monitoring is recommended for inactive carrier and immune-tolerant CHB patients. However, a substantial proportion of patients fall into an indeterminate phase whose serum HBV DNA and alanine aminotransferase levels do not fit well into these well-described phases. Most of CHB patients with indeterminate phase are HBeAg negative. However, the clinical outcomes of these patients remain unclear. Therefore, the purpose of this study is to investigate the clinical outcomes of HBeAg-negative chronic hepatitis B patients with indeterminate phase.

NCT ID: NCT05637541 Recruiting - Chronic Hepatitis b Clinical Trials

Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets

Start date: November 23, 2022
Phase: Phase 2
Study type: Interventional

A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.

NCT ID: NCT05621304 Recruiting - Clinical trials for Chronic Hepatitis B Virus (Hbv)

Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)

Start date: January 3, 2017
Phase:
Study type: Observational

Background: People who were born outside of the country are the largest group of adults infected with chronic hepatitis B virus (HBV) in the US. HBV affects the liver. If not treated, HBV infection can lead to serious liver disease, including cancer. One recent study showed that only 35% of foreign-born US adults were aware of their HBV infections. Foreign-born US adults may also have trouble getting proper care after they are diagnosed with HBV. In one small survey, language, cultural, and financial barriers were cited as the biggest reasons for not receiving care. To help more people with HBV, researchers want to learn how to find and overcome any barriers to care. Objective: This natural history study seeks to identify and better understand barriers that prevent foreign-born US adults from getting proper care for HBV infections. Eligibility: People aged 18 years and older with chronic HBV who were born outside of the US. Design: Participants will visit the NIH clinic 1 time. This visit will take about 20 minutes. Researchers will review participants medical records and collect information about their HBV. Participants will complete a survey. They will answer questions about: Where they came from. When they came to the US. How well they have adapted to living in the US. The health care they have received for HBV. Their age, gender, and education. Participants will be paid $10 for completing the survey. ...

NCT ID: NCT05583006 Recruiting - Clinical trials for Patient Satisfaction

Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

Start date: November 6, 2023
Phase:
Study type: Observational

Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration rate (eGFR). However, tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with CHB, and is convenient in drug taking, i.e., once daily regardless food taking and renal function.Therefore,TAF can be a good option in CHB patients who are unsatisfied to ETV therapy. The aim of this prospective cohort study is to assess the improvement on satisfaction (including drug adherence) of TAF switch therapy in CHB patients who are unsatisfied to ETV therapy. In addition, with expected adherence improvement in TAF switch therapy, the efficacy of TAF switch therapy may be improved, and the efficacy benefits can be evaluated by the changes of some novel biomarkers, such as HBV core-related antigen (HBcrAg). The investigators therefore aim to conduct a prospective cohort study of TAF switch therapy for CHB patients who are unsatisfied to ETV therapy.

NCT ID: NCT05551273 Recruiting - HIV Infections Clinical Trials

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

Start date: May 5, 2023
Phase: Phase 2
Study type: Interventional

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level >1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.