Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07429864

Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.

Official title: Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-09-24

Completion Date

2027-10

Last Updated

2026-02-24

Healthy Volunteers

No

Locations (1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD

Roma, Italy