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Hepatitis, Chronic clinical trials

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NCT ID: NCT06323681 Recruiting - Chronic Hepatitis b Clinical Trials

Pegylated Interferon α in Previously Interferon-treated CHB(Leading Study)

Start date: February 4, 2024
Phase: N/A
Study type: Interventional

Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy. This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.

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: NCT06295328 Recruiting - Chronic Hepatitis b Clinical Trials

From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

HepBTer
Start date: April 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB). Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group. Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial. Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir > 6 months (group B, n=16). Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B). Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg >0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA >0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage.

NCT ID: NCT06289725 Recruiting - Chronic Hepatitis b Clinical Trials

Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B

Start date: January 1, 2024
Phase:
Study type: Observational

The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.

NCT ID: NCT06263959 Recruiting - Chronic Hepatitis B Clinical Trials

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B

Start date: December 29, 2023
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B

NCT ID: NCT06248580 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Find HDV and Determine Its Status in Turkey

SITUHDVATION
Start date: January 31, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of these study to determine the prevalence of HDV infections and the prognosis of HDV patients in Turkey's southeast. We intend to arrange training sessions for 250 family physicians in Diyarbakır, Batman, Mardin, and Şanlıurfa in order to determine those goals. We will talk about diagnosing HBV, HDV, HCV, and HIV infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

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: February 16, 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.