Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide (NCT07429864) | Clinical Trial Compass
RecruitingNot Applicable
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Italy20 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.