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Hepatitis A clinical trials

View clinical trials related to Hepatitis A.

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NCT ID: NCT06122285 Recruiting - Hepatitis D Clinical Trials

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

D-SHIELD
Start date: May 1, 2023
Phase:
Study type: Observational

Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy. HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.

NCT ID: NCT06121427 Recruiting - Chronic Hepatitis D Clinical Trials

Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA

Start date: September 1, 2023
Phase:
Study type: Observational

This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflammation according to blood chemistry parameters, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice. After the patient has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least once times every 4 weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the patient's participation in the study will be terminated. The collected data will be analyzed to assess the probability of relapse-free over time. Separate tests will also be conducted for subgroups of patients based on covariates such as duration of previous background therapy with bulevirtide, duration of HDV suppression, use of any other concomitant antiviral therapy during bulevirtide treatment.

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: NCT06078098 Recruiting - Clinical trials for Autoimmune Hepatitis

Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage

AIH Database
Start date: March 29, 2023
Phase:
Study type: Observational [Patient Registry]

Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown. This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects > 1 years old in Italy.

NCT ID: NCT06051045 Recruiting - Chronic Hepatitis D Clinical Trials

Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients

SEE-D
Start date: September 27, 2023
Phase:
Study type: Observational

The aim is to assess the efficacy and specific safety in an observational study of patients with Chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +/- PEG-IFNα-2a and +/- NA given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and/or intrahepatic markers/signatures, and quality of life outcomes will be assessed.

NCT ID: NCT06049602 Recruiting - Clinical trials for Hepatitis B Reactivation

TDF and Entekavir - Hepatitis B Reactivation

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

This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.

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.

NCT ID: NCT06023745 Recruiting - Clinical trials for Hepatitis B, Chronic

Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.

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

Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \ Irsin (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis B group. - Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B. - Asses the correlation between SOD serum level and the risk of chronic hepatitis B.

NCT ID: NCT06023056 Recruiting - Clinical trials for Blood Transfusion Complication

Hepatitis B Vaccination After Neonatal Surgery

Start date: November 1, 2022
Phase:
Study type: Observational [Patient Registry]

At present, whether the hepatitis B vaccine (HBV) can be vaccinated on time after neonatal surgery has become a common problem for children's families, neonatal surgeons, and vaccination departments, but there are few relevant studies at home and abroad, and there is no corresponding guide or consensus. In the early stage, our research team investigated the vaccination plans of the vaccination units in the main urban areas of Chongqing for such children through telephone follow-up, and found that the practices of each unit were different, all based on their own experience, and there was no clear evidence to support the vaccination or should not be vaccinated, which may cause some children to miss the best vaccination time or increase the risk of vaccination. The center is a relatively large neonatal surgery center in southwest China. The diagnosis and treatment of neonatal digestive tract malformations is at the leading level in China. It can carry out various neonatal operations such as neonatal necrotizing enterocolitis, congenital anorectal malformations, and congenital megacolon. On average, it carries out more than 30 third and fourth grade neonatal gastrointestinal operations every month. It has accumulated a lot of experience in the follow-up of newborns, There is a large amount of clinical data support for children who need to be vaccinated after surgery, so it is planned to follow up the second and third doses of hepatitis B vaccine and whether there are adverse reactions related to vaccination for children who need to be vaccinated after gastrointestinal surgery in the neonatal period, and at the same time check the production of HBsAb after vaccination, The immune response and adverse reactions of hepatitis B vaccine at different time points after surgery were studied to increase clinical evidence for the determination of hepatitis B vaccine vaccination program for newborns after surgery.

NCT ID: NCT06010524 Recruiting - Hepatitis C Clinical Trials

A Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX

VOSEVI_Reg
Start date: February 1, 2023
Phase:
Study type: Observational

This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study. Patients data will be collected from hospital medical records.