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Study identifier: NCT07429864 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: HBV · HBV Coinfection · HCV  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseN/A
Planned participants20
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Francesca Romana Ponziani  ·  +390630159336  ·  francescaromana.ponziani@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMADRoma, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07429864