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Hepatitis B, Chronic clinical trials

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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: May 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: NCT06150014 Recruiting - Chronic Hepatitis b Clinical Trials

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Start date: December 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, double-blind Phase Ib/IIa multicenter trial. All eligible subjects will receive TQA3605 tablets or placebo in combination with nucleoside (acid) analogues. A total of 64 subjects will be enrolled.

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.

NCT ID: NCT06128421 Recruiting - Malnutrition Clinical Trials

Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk

Start date: November 23, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk

NCT ID: NCT06115993 Recruiting - Clinical trials for Hepatitis B, Chronic

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and Chronic Hepatitis B Patients

Start date: August 3, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses. In addition, the study will evaluate the antiviral efficacy of AHB-137 in chronic hepatitis B (CHB) patients following a multiple dosing regimen.

NCT ID: NCT06092333 Not yet recruiting - Chronic Hepatitis B Clinical Trials

VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

Start date: May 19, 2024
Phase: Phase 2
Study type: Interventional

Background: Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited. Objective: To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection. Eligibility: People aged 18 to 65 years with mild or inactive HBV infection. Design: Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver. Participants will be in the study for over 2 years. VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months. Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections. Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months. Participants will have two 3-day stays in the hospital. Tests will include: Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours. Fine needle aspiration. A small needle will be used to collect cells from the liver. After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.

NCT ID: NCT06085053 Recruiting - Chronic Hepatitis b Clinical Trials

A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Start date: November 30, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics. In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).

NCT ID: NCT06070051 Recruiting - Chronic Hepatitis B Clinical Trials

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy

Start date: September 26, 2023
Phase: Phase 1
Study type: Interventional

This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of hepatitis B virus (HBV) core and polymerase antigens fused within glycoprotein D in a cohort of chronic hepatitis B (CHB)-infected adult participants who are currently receiving entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine, with documented HBV viral load suppression for at least 12 months. Approximately 24 participants will be enrolled in Group 1 and randomized to Cohort 1a or Cohort 1b. Those assigned to Cohort 1a will receive a low dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 1b will receive a low dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination. Group 2 will then enroll approximately 24 participants randomized to Cohort 2a or Cohort 2b. Those assigned to Cohort 2a will receive a high dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 2b will receive a high dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination. All vaccine doses will be administered by intramuscular (IM) injection. All study participants will be followed for a total of 1 year post-prime vaccination.

NCT ID: NCT06068140 Not yet recruiting - Clinical trials for Chronic Viral Hepatitis B With Delta-Agent

Evaluation of the Effectiveness of the Complex of Carnitine Orotate and Biphenyl Dimethyl Dicarboxylate in the Adjuvant Therapy of Chronic Hepatitis D in Real Clinical Practice: a Prospective Cohort Study

Start date: December 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study

NCT ID: NCT06047093 Recruiting - Chronic Hepatitis b Clinical Trials

Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients

RES-HBV
Start date: March 8, 2024
Phase: N/A
Study type: Interventional

Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation). The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection. The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.