Trials / Recruiting
RecruitingNCT07429864
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- HBV
- HBV Coinfection
- HCV
- HIV Infections
- Hepatocellular Carcinoma
- Cirrhosis, Liver
- Fibrosis, Liver
- Bile Acid Malabsorption
- Microbial Colonization
Timeline
- Start date
- 2025-09-24
- Primary completion
- 2027-10-01
- Completion
- 2027-10-01
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07429864. Inclusion in this directory is not an endorsement.