Bile acid and gut bacteria changes in people with hepatitis D taking bulevirtide
Observes bile acids and gut bacteria in adults with hepatitis D treated with bulevirtide.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 24 Sept 2025
- Expected to end
- Oct 2027
- Type of study
- Observational
- Record updated
- 24 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis D, or mild compensated cirrhosis, who have just been prescribed bulevirtide 2 mg and are on HBV antiviral treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)
- Earlier treatment
- Must be on antiviral therapy for HBV. First bulevirtide 2 mg prescription within the 30 days before joining. No antibiotics, probiotics or prebiotics in the month before joining.
- Biomarker or test result
- Positive HDV RNA within the 24 weeks before joining
Main reasons for not taking part
- Decompensated liver cirrhosis (Child-Pugh B or C)
- No HBV-HDV-related infection, hepatitis or cirrhosis
- Pregnant or breastfeeding women
- Illness with short life expectancy (cancer, heart failure NYHA III/IV, COPD GOLD C-D)
- Conditions or medicines that can change the gut microbiota (celiac disease, chronic inflammatory bowel disease, antibiotics, probiotics, prebiotics)
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D)
- Patients without HBV-HDV-related infection/hepatitis/cirrhosis
- Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition
- Age ≤18 years
- Decompensated liver cirrhosis (Child-Pugh Score B or C)
- Pregnant or breastfeeding women
Where in Italy
- Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMADRoma, ItalyContact: Francesca Romana PonzianiTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
- Plain-language title
- Bile acid and gut bacteria changes in people with hepatitis D taking bulevirtideGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 February 2026