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Hepatitis B, Chronic clinical trials

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NCT ID: NCT06452693 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

NCT ID: NCT06425341 Not yet recruiting - Chronic Hepatitis B Clinical Trials

A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.

NCT ID: NCT06384131 Not yet recruiting - Chronic Hepatitis B Clinical Trials

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.

NCT ID: NCT06221605 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Regulation of Intestinal Flora by Compound Probiotics in Patients With Chronic Hepatitis B

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this is to verify the clinical efficacy of compound probiotics in reducing HBV infection levels and regulating intestinal flora in patients with chronic hepatitis B. The main question it aims to answer is: • Conventional antiviral therapy combined with a 6-month probiotic intervention was used to evaluate the clinical efficacy of reducing HBV infection levels (HBeAg, HBsAg, and HBV DNA levels) and regulating gut microbiota.

NCT ID: NCT06190002 Not yet recruiting - Clinical trials for Acute-on-chronic Hepatitis B Liver Failure

Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure

Start date: January 20, 2024
Phase:
Study type: Observational

This is a single-center retrospective study. The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected.

NCT ID: NCT06184347 Not yet recruiting - Cirrhosis Clinical Trials

Population-wide Research for HBV-related Liver Diseases in Maoming City

PreMAO
Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

Hepatitis B virus (HBV) infection is a major public health problem and chronic HBV infection affects about 296 million people worldwide and is the leading etiology of cirrhosis and hepatocellular carcinoma globally. China takes up a great deal of the responsibility towards the goal of "eliminating viral hepatitis by 2030" released by the World Health Organization (WHO), as China has the world's largest burden of HBV infection. The current diagnostic rate barely reaches 24%, which is significantly short of the target diagnostic rate of 90% proposed by WHO. Progression from chronic hepatitis B (CHB) to hepatic complications-fibrosis, cirrhosis, and HCC-can be prevented significantly by preemptive antiviral therapy. However, the onset of CHB seldom manifests with typical symptoms, and most cases at their first diagnosis have progressed to end-stage liver diseases. Therefore, early detection of CHB and its complications that not only raises public awareness of preventing infection but also brings the patients into the management system is urgent blocking the progression to cirrhosis and HCC. The study is a prospective and observational study involving community-based screening of chronic HBV infection and related liver diseases systematically among the general population of Guangdong Province, China. Individuals in Maoming City, aged 20-70 years, will be enrolled in the screening group for the HBsAg screening using a finger blood test. Positive participants will receive further examinations including laboratory and imaging examinations to discover HBV-related liver diseases. The control group will be enrolled from the general population in two similar cities. By thoroughly investigating the epidemiological landscape and antiviral situation of chronic hepatitis B through population screening, this study intends to furnish the administration with updated epidemiological data. Additionally, the project seeks to establish a CHB screening cohort to enhance early diagnosis and treatment rates for both HBV-related liver diseases. Collectively, the study aspires to improve the overall prognosis for patients with chronic HBV infection, reduce CHB-related mortality, and ultimately put forward valuable healthcare insights and evidence-based medicine (EBM) practices for the effective implementation of CHB screening and management.

NCT ID: NCT06162299 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Phase I, The Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002

Start date: May 30, 2024
Phase: Phase 1
Study type: Interventional

This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL.

NCT ID: NCT06159062 Not yet recruiting - Clinical trials for Chronic Hepatitis B Virus Infection

A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection

Start date: February 27, 2024
Phase: Phase 1
Study type: Interventional

The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection.

NCT ID: NCT06154278 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B

i-LIVER
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are: - how well is it working in the liver - how does Imdusiran affect the hepatitis B virus Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.

NCT ID: NCT06130137 Not yet recruiting - Chronic Hepatitis b Clinical Trials

Gut Microbiome in People Living With HIV and HBV

Start date: November 27, 2023
Phase:
Study type: Observational

Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.