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NCT Number: NCT07429864

Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

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.

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Key information

Conditions

HBV Adenocarcinoma Bile Acid Malabsorption Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Cirrhosis, Liver Communicable Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Dysbiosis Fibrosis Fibrosis, Liver Genital Diseases HBV Coinfection HCV HIV Infections Hepatocellular Carcinoma Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Cirrhosis Liver Diseases Liver Neoplasms Microbial Colonization Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis

    Time frame: 2-18 months

    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

  2. Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response

    Time frame: 2-24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Romana Ponziani

CONTACT

[email protected]

+390630159336

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection

Acronym: Bio-Delta

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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