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Hepatitis clinical trials

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NCT ID: NCT05967650 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood. Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine

NCT ID: NCT05962307 Completed - Hepatitis D Clinical Trials

Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

HEP4Di
Start date: April 1, 2023
Phase:
Study type: Observational

Spontaneous, pharmacological observational, no-profit, retrospective, multi-center. 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 retrospectively/longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, 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. All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.

NCT ID: NCT05961098 Recruiting - Chronic Hepatitis b Clinical Trials

A Study of RBD1016 in CHB Participants

Start date: August 21, 2023
Phase: Phase 2
Study type: Interventional

This study consists of Part A and Part B. Part A is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with NAs in CHB participants. Part B is a multi-center, open clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with PegIFN-α and NAs in CHB participants.

NCT ID: NCT05957380 Recruiting - Hepatitis B Clinical Trials

Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

Start date: March 20, 2023
Phase: Phase 4
Study type: Interventional

This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects

NCT ID: NCT05956379 Enrolling by invitation - Clinical trials for Non-alcoholic Fatty Liver Disease

Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.

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

In Taiwan, HBV infection is endemic in the adult population. With the westernization of eating habit and lifestyle, metabolic syndrome and related non-alcoholic fatty liver diseases (NAFLD, newly proposed as metabolic dysfunction associated fatty liver diseases, MAFLD) has become another important health issue. It is therefore common to encounter subjects with concurrent MAFLD and HBV infection in HBV endemic countries. This project will study the clinical data of patients with concurrent MAFLD and HBV, and aim to explore the impact of exercise intervention on the hepatic fatty infiltration, alteration of gut microbiota and HBV replication status in this group of patients. The research strategies will include (1) improving fatty liver and metabolic syndrome in subjects with concurrent MAFLD and HBV; and (2) exploring the changes of HBV replication and intestinal microflora in patients with concurrent HBV and MAFLD after exercise intervention.

NCT ID: NCT05953545 Withdrawn - Clinical trials for Chronic Hepatitis Delta

Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis

Start date: May 22, 2024
Phase: Phase 2
Study type: Interventional

Background: Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications are approved to treat chronic hepatitis D. Objective: To test a combination of 3 drugs in people with chronic hepatitis D. Eligibility: People 18 years or older with chronic hepatitis D. Design: Participants will be in the study about 2 years. They will have 3 inpatient stays of 3 to 5 days. Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function and an ultrasound: a wand that uses sound waves to create images of the liver will be rubbed over the skin on their torso. Participants will stay in the clinic for a 3-day baseline visit. They will have imaging scans, an eye exam, and a visit with a reproductive specialist. They will have a liver biopsy: about 1 inch of liver tissue will be removed, either with a tube inserted through a vein in the neck, or with a needle inserted through the participant s side. Participants will take the study drugs for 48 weeks. Two of them are tablets taken twice a day at home; 1 is a shot administered once a week. Participants will begin taking the drugs during a 5-day stay in the clinic. Then they will have 15 outpatient visits while taking the drugs and 7 more after they finish. The last 3-day clinic stay will be 6 months after participants finish taking the drugs. The liver biopsy, imaging scans, and other tests will be repeated.

NCT ID: NCT05949814 Recruiting - HIV Infections Clinical Trials

Acceptability of a PrEP Program Among MSM and Transgender (TG) and Having Accepted a Targeted Screening for HIV, Hepatitis B (VHB), Hepatitis C (VHC) and STIs.

Easy-Tests
Start date: July 30, 2023
Phase:
Study type: Observational

Acceptability of a PrEP program among MSM and TG visiting a geolocated community application or a community physical place of sociability and having accepted a targeted screening for HIV, Hepatitis B, C and STIs.

NCT ID: NCT05948982 Not yet recruiting - Clinical trials for Decompensated Liver Cirrhosis

Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis

Start date: July 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future. Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.

NCT ID: NCT05942937 Recruiting - HCV Clinical Trials

National Prisons Hepatitis Education Project: Research Evaluation

HepPEd
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

The National Prisons Hepatitis Education Program (HepPEd Program) is a national, prison-based hepatitis C health literacy education program for healthcare providers, correctional officers, and people in prison. The HepPEd Program aims to improve the public health literacy of the prison sector regarding hepatitis C in prisons. The HepPEd: Research Evaluation aims to evaluate the impact of the HepPEd Program on HCV testing and treatment uptake amongst people incarcerated in Australian prisons, as well as changes in knowledge, attitudes, and capabilities of healthcare providers, correctional officers, and people in prison. The study is a controlled before and after study being conducted in 3-6 correctional centres in Australia.

NCT ID: NCT05937178 Recruiting - Clinical trials for Hepatitis B, Chronic

Real-world Study Optimizing Nucleotide-analogues

Start date: January 31, 2023
Phase:
Study type: Observational

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are: 1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019. 2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment. 3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.