NCT07429864 Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
| NCT ID | NCT07429864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | HBV |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-09-24 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Francesca Romana Ponziani
PRINCIPAL INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07429864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HBV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07429864 currently recruiting?
Yes, NCT07429864 is actively recruiting participants. Contact the research team at francescaromana.ponziani@policlinicogemelli.it for enrollment information.
Where is the NCT07429864 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07429864 clinical trial?
NCT07429864 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Francesca Romana Ponziani at Fondazione Policlinico A. Gemelli IRCCS. The trial plans to enroll 20 participants.