HBVBio-DeltaNCT07429864
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
An observational study of HBV and HBV Coinfection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV, HBV Coinfection, HCV
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 24 Sep 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis or compensated liver cirrhosis (Child-Pugh Score A) related to HBV-HDV, at the time of the first prescription of BLV 2 mg, will be enrolled.
Who may be able to join
- 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
Show all 9Show fewer
- Normocaloric omnivorous diet
- No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD
Roma, 00168
Francesca Romana Ponziani, 3471227242, francescaromana.ponziani@policlinicogemelli.it
Elisabetta Creta, +393480778584 ext. +390630159336, elisabetta.creta@policlinicogemelli.it
About this study
Official title: Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
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.
- Conditions
- HBV, HBV Coinfection, HCV, HIV Infections, Hepatocellular Carcinoma, Cirrhosis, Liver
- Keywords
- gut microbiota, Bile Acids, dysbiosis
- Medical subject headings
- HIV Infections, Carcinoma, Hepatocellular, Liver Cirrhosis, Communicable Diseases, Dysbiosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota in HBV-HDV Patients on Bulevirtide
To describe the composition of the intestinal microbiota (IM)of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Measured: 2-18 months
Bile Acids in HBV-HDV Patients on Bulevirtide
To describe the composition of the fecal bile acids (BA) of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Measured: 2-18 months
Inflammation in HBV-HDV Patients on Bulevirtide
To describe the systemic inflammatory of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Measured: 2-18 months
Secondary outcomes (2)
Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis
assess characteristics common to patients with chronic hepatitis or compensated liver cirrhosis HBV-HDV related to the first prescription of BLV 2 mg by examining their clinical and demographic history
Measured: 2-18 months
Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response
To assess whether the composition of the intestinal microbiota (IM) and fecal bile acids (BA) is correlated with treatment efficacy at weeks 24, 48, and 96.
Measured: 2-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start24 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ponziani Francesca Romana, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesca Romana Ponziani, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429864
- Sponsor's protocol ID
- 7914
- Acronym
- Bio-Delta
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
- ClinicalTrials.gov ID
- NCT07429864
- Acronym / sponsor ID
- Bio-Delta / 7914
- Conditions
- HBV, HBV Coinfection, HCV, HIV Infections, Hepatocellular Carcinoma, Cirrhosis, Liver
- Keywords
- gut microbiota, Bile Acids, dysbiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis or compensated liver cirrhosis (Child-Pugh Score A) related to HBV-HDV, at the time of the first prescription of BLV 2 mg, will be enrolled.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut Microbiota in HBV-HDV Patients on Bulevirtide
Time frame: 2-18 months
To describe the composition of the intestinal microbiota (IM)of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Bile Acids in HBV-HDV Patients on Bulevirtide
Time frame: 2-18 months
To describe the composition of the fecal bile acids (BA) of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Inflammation in HBV-HDV Patients on Bulevirtide
Time frame: 2-18 months
To describe the systemic inflammatory of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
2 secondary outcomes
Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis
Time frame: 2-18 months
Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response
Time frame: 2-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Romana Ponziani principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV and HBV Coinfection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Romana Ponziani (+390630159336, francescaromana.ponziani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota in HBV-HDV Patients on Bulevirtide (time frame: 2-18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.