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Hepatitis B, Chronic clinical trials

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NCT ID: NCT06431438 Completed - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

Start date: October 1, 2021
Phase: Phase 1
Study type: Interventional

This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.

NCT ID: NCT05839639 Completed - Chronic Hepatitis B Clinical Trials

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

Start date: October 9, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.

NCT ID: NCT05753280 Completed - Chronic Hepatitis b Clinical Trials

Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells, dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies have been carried out at home and abroad. In this study, We will recruit CHB patients with low HBsAg levels. They all will receive pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a control group. A final assessment will be made to determine whether vitamin D levels would affect the clearance rate of HBsAg.

NCT ID: NCT05678582 Completed - Chronic Hepatitis Clinical Trials

Hepatic Steatosis and Chronic Hepatitis B Virus

Start date: January 1, 2023
Phase:
Study type: Observational

This study aims to evaluate the prevalence and severity of hepatic steatosis in CHB and investigate the relationship between hepatic steatosis and viral load, liver biochemistry, liver fibrosis, and inflammation in CHB

NCT ID: NCT05569941 Completed - Chronic Hepatitis B Clinical Trials

A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

Start date: November 11, 2022
Phase: Phase 1
Study type: Interventional

This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.

NCT ID: NCT05560503 Completed - Liver Fibrosis Clinical Trials

A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection

Start date: January 1, 2017
Phase:
Study type: Observational

Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.

NCT ID: NCT05523648 Completed - Chronic Hepatitis B Clinical Trials

Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Start date: January 5, 2020
Phase: Early Phase 1
Study type: Interventional

The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.

NCT ID: NCT05470829 Completed - Healthy Volunteers Clinical Trials

A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R

Start date: May 27, 2021
Phase: Phase 1
Study type: Interventional

This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Study of Part II was carried out following the safety assessment and racial difference evaluation in Part I.

NCT ID: NCT05451420 Completed - Chronic Hepatitis B Clinical Trials

Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

NCT ID: NCT05435599 Completed - Chronic Hepatitis b Clinical Trials

Serum Regucalcin Level and Chronic Hepatitis B

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.