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Hepatitis clinical trials

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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: NCT06250309 Recruiting - Clinical trials for Autoimmune Hepatitis

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

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

This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.

NCT ID: NCT06248580 Recruiting - Clinical trials for Hepatocellular Carcinoma

Find HDV and Determine Its Status in Turkey

SITUHDVATION
Start date: March 11, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (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: NCT06216470 Recruiting - Clinical trials for Hepatitis B, Chronic

Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

NCT ID: NCT06196632 Recruiting - Clinical trials for Hepatitis B, Chronic

Development and Validation of Models to Predict Functional Cure in Patients With CHB After Peg-IFN Based Therapy

Start date: January 6, 2024
Phase:
Study type: Observational

Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of Peg-IFNα and NAs, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In this study, we aim to establish logistic regression models to predict durable functional cure in patients with CHB treated by combination of Peg-IFNα and NAs, which might be useful for clinical physicians to make personalized treatment decisions. These models will be constructed using baseline routine clinical laboratory indicators with high diagnostic accuracy. These models might be widely applicable to almost all medical institutions and will effectively promote the application of Peg IFN α plus NAs therapy in clinical work. The findings in this study might greatly improve the functional cure rate of CHB and reducing the incidence rate and mortality of HBV related end-stage liver diseases.

NCT ID: NCT06179498 Recruiting - Hepatitis C Clinical Trials

Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).

NCT ID: NCT06159244 Recruiting - Clinical trials for Intestinal Microbiota

Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

HepatAlc-IM
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response. The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes. The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment. The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.

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: NCT06137313 Recruiting - Hepatitis E Clinical Trials

Exposure to Hepatitis E Virus in Occitania, France

EVE
Start date: December 15, 2023
Phase:
Study type: Observational

The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania. Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar

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.