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Hepatitis, Chronic clinical trials

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NCT ID: NCT05786963 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

Start date: December 29, 2022
Phase:
Study type: Observational

Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.

NCT ID: NCT05766449 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With CHB and NAFLD

Start date: June 1, 2022
Phase:
Study type: Observational

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models for hepatic inflammation, fibrosis in patients with CHB associated NAFLD. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.

NCT ID: NCT05763576 Recruiting - Chronic Hepatitis B Clinical Trials

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

Start date: April 28, 2023
Phase: Phase 1
Study type: Interventional

This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).

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: 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: NCT05718700 Recruiting - Clinical trials for Chronic Hepatitis D Infection

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Start date: February 7, 2023
Phase:
Study type: Observational [Patient Registry]

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

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: NCT05630820 Recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

B-Well 2
Start date: December 6, 2022
Phase: Phase 3
Study type: Interventional

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.