NCT07429864Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 12 Sept 2025
- Start date
- 24 Sept 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- HIV, Liver and biliary tract cancer
- NCT number
- NCT07429864
What you commit to
- Study type: Observational
- Planned participants: 20
- From 24 Sept 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D)
Other illness
- 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
- Age ≤18 years
Other
- Decompensated liver cirrhosis (Child-Pugh Score B or C)
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.