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Hepatitis D clinical trials

View clinical trials related to Hepatitis D.

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NCT ID: NCT05953545 Withdrawn - Clinical trials for Chronic Hepatitis Delta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: NCT05936073 Recruiting - Hepatitis D Clinical Trials

DELTA DESCRIBE: the French Collaborative Project

DELTADESCRIBE
Start date: March 1, 2023
Phase:
Study type: Observational

Our global objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, the first step for specialized care pathway in metropolitan France.

NCT ID: NCT05928000 Recruiting - Hepatitis D Clinical Trials

HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV

HERACLIS-BLV
Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to assess the efficacy and safety of bulevirtide (BLV) in chronic hepatitis D patients treated in Greek liver centers.

NCT ID: NCT05903742 Recruiting - Hepatitis D Clinical Trials

Standardising Care for Hepatitis Delta in the Netherlands

DREAM-2
Start date: January 22, 2024
Phase:
Study type: Observational

Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary. Objective: Generate prospective follow-up data to increase our understanding of this rare disease. Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections

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: 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: NCT05765344 Recruiting - Clinical trials for Chronic Hepatitis D Infection

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

Start date: March 15, 2023
Phase: Phase 1
Study type: Interventional

The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function.

NCT ID: NCT05760300 Recruiting - Clinical trials for Chronic Hepatitis D Infection

A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function

Start date: March 15, 2023
Phase: Phase 1
Study type: Interventional

The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.

NCT ID: NCT05723068 Recruiting - Chronic Hepatitis D Clinical Trials

Burden of Hepatitis D Virus (HDV) Infection in Italy

HDV Describe
Start date: August 24, 2022
Phase:
Study type: Observational

The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.

NCT ID: NCT05718700 Recruiting - Clinical trials for Chronic Hepatitis D Infection

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Start date: February 7, 2023
Phase:
Study type: Observational [Patient Registry]

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.