🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

Recruitingn/aAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT07429864 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A) * Positive HDV RNA within the 24 weeks prior to enrollment * Ongoing antiviral therapy for HBV at the time of enrollment * First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment * Caucasian ethnicity * Age ≥18 years * Normocaloric omnivorous diet * No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment * Signed informed consent Exclusion Criteria: * Decompensated liver cirrhosis (Child-Pugh Score B or C) * Patients without HBV-HDV-related infection/hepatitis/cirrhosis * Age ≤18 years * Pregnant or breastfeeding women * Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D) * Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition
💊

What it tests

  • Not listed
📍

Where

1 site
Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy