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Hepatitis, Chronic clinical trials

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NCT ID: NCT05874440 Recruiting - Clinical trials for Chronic Hepatitis b Patients

Clinical Efficacy and Safety of Tenofovir Disoproxil Fumarate and Entcavir in Treatment of Chronic Hepatitis B Patients in Upper Egypt

Start date: April 15, 2023
Phase:
Study type: Observational

Chronic hepatitis B (CHB) is one of the major causes of chronic liver diseases worldwide. Around 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections each year and more than 820 thousand people die because of hepatitis B virus (HBV) related complications

NCT ID: NCT05871749 Not yet recruiting - Chronic Hepatitis b Clinical Trials

Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B

Start date: May 20, 2023
Phase:
Study type: Observational

The investigator aimed to prospectively study the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.

NCT ID: NCT05861674 Recruiting - Clinical trials for Chronic Hepatitis Delta Virus Infection

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

Start date: June 16, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.

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: NCT05828745 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B

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

CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.

NCT ID: NCT05827146 Completed - Clinical trials for Chronic Hepatitis D Infection

Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Start date: October 7, 2023
Phase: Phase 2
Study type: Interventional

A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D

NCT ID: NCT05808374 Recruiting - Chronic Hepatitis B Clinical Trials

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

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

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.

NCT ID: NCT05808335 Recruiting - Chronic Hepatitis B Clinical Trials

A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)

Start date: January 11, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose and hzVSF-v13 200 mg/dose in combination with an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.

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.

Promote
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).