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Hepatitis B, Chronic clinical trials

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NCT ID: NCT06379334 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population

Start date: December 6, 2020
Phase:
Study type: Observational

Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC.

NCT ID: NCT06311734 Active, not recruiting - Chronic Hepatitis B Clinical Trials

A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

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

To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .

NCT ID: NCT06000657 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir

Start date: August 28, 2023
Phase: Phase 4
Study type: Interventional

Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.

NCT ID: NCT05970289 Active, not recruiting - Clinical trials for Chronic Hepatitis B Virus Infection

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Start date: August 22, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

NCT ID: NCT05905731 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Autologous T-cells Transfected With mRNA Encoding HBV-TCR T Cell Therapy in Combination With NUC for Chronic Hepatitis B

Start date: June 1, 2023
Phase: Phase 1
Study type: Interventional

This is a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. This study will be conducted sequentially starting with Stage-1, followed by Stage-2.

NCT ID: NCT05905458 Active, not recruiting - Chronic Hepatitis B Clinical Trials

A Phase II Clinical Study of the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)

Start date: July 28, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).

NCT ID: NCT05797714 Active, not recruiting - Chronic Hepatitis b Clinical Trials

The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.

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Start date: June 8, 2022
Phase: N/A
Study type: Interventional

This is a multicenter, randomized, open, blank controlled trial ,in order to evaluate the effectiveness and safety of Amibufenamide(TMF) in the treatment of chronic hepatitis B virus infection patients with normal ALT .

NCT ID: NCT05793268 Active, not recruiting - Chronic Hepatitis b Clinical Trials

Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B

Start date: December 20, 2022
Phase: N/A
Study type: Interventional

BACKGROUND: Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and efficacy of this treatment strategy. AIMS: The investigators aimed to evaluate the safety and efficacy of finite Nuc therapy versus continuous treatment in CHB patients without liver cirrhosis and also to identify factors that may predict therapeutic responses and clinical outcomes after withdrawal of Nuc treatment for CHB MATERIAL AND METHODS: This is a multicenter randomized controlled trial conducted in Taiwan. Eligible patients are adults (age≥20 years) with CHB (chronic infection ≥ 6 months) who fulfill the APASL guideline 2016 to stop NA therapy. Those with cirrhosis, malignancy, organ transplant, autoimmune disorder, or serious underlying diseases including renal impairment were excluded. A total of 360 patients will be enrolled. Enrolled patients are randomly allocated with a 1:1 ratio to continue viral suppression with entecavir (0.5mg once daily) or tenofovir disoproxil fumarate (300mg once daily) or stop the treatment. All patients will be followed up according to the protocol recommended by a panel of APASL experts. The primary analysis for study outcomes is scheduled at 3 years after randomization and the primary outcome is seroclearance of HBsAg. There will be interim analyses scheduled at one- and two-years following randomization of the first 200 patients, and also one-and two years following randomization of the planned 360 patients, to determine whether early termination of the trial may be justified by attainment of the efficacy endpoint (10% vs 1% of HBsAg seroclearance) or concerns of the safety outcomes (significant between-group difference in mortality, acute on chronic liver failure, or acute flares with hepatic decompensation).

NCT ID: NCT05770895 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B

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

The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.

NCT ID: NCT05734807 Active, not recruiting - Clinical trials for Chronic HBV Infection

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

Start date: July 20, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.