Completed

NCT Number: NCT07116044

Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection

1. The study is non-interventional, multicenter, non-profit 2. The primary objective of the study is to evaluate the safety and efficacy in clinical practice of the drug Bulevirtide in the treatment of patients with chronic HDV hepatitis. The drug is already approved and indicated in the treatment of patients with the aforementioned infectious pathology. 3. The Coordinating Center and the Principal Investigator of the study in question will be, respectively, the Department of Medical Health Sciences "V. Tiberio" and the undersigned Prof. Luca Rinaldi in cooperation with the Azienda dei Colli, Cotugno Hospital in Naples, Dr Antonio Izzi. 4. As regards the further economic aspects, it is underlined that no compensation of any kind is foreseen for the subjects participating in the study and that there are no expenses borne by the subjects participating in the study. The study will be coordinated, managed and analyzed independently.

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Key information

Conditions

Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli studi del molise

Campobasso, Seleziona, 86100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with HDV and HBV-related liver disease considered suitable for antiviral or immunomodulatory treatment.

Absence of contraindications to the use of Bulevirtide
Age over 18 years.
Patients born to therapy or already undergoing cycles of therapy with standard interferon or pegylated.
Informed consent to study participation

Exclusion criteria

Specific contraindications to bulevirtide • Presence of decompensated liver disease or other conditions that may interfere with study participation or interpretation of results

Treatment and study plan

virological tests diagnostic tests

Diagnostic Test

The parameters collected will include blood sugar, HbA1c, complete blood count, lipid profile (total cholesterol, LDL, HDL, triglycerides), liver profile (ALT, AST, total and fractionated bilirubin, alkaline phosphatase, GGT) and renal profile (creatinine, azotemia), electrophoretic protein picture. Additionally, specific data for HDV and HBV infection will be collected, including HBsAg, anti-HBs, anti-HBc, HBV-DNA, and HDV-RNA. The glomerular filtration rate shall be calculated using the formula CKD-EPI.

Instrumental Tests: Results of abdominal ultrasounds, Fibroscan®/CAP for the evaluation of liver fibrosis

Primary outcomes

Efficacy of bulevirtide

Time frame: 12 months

Evaluate the virological response to treatment with bulevirtide, measured as reduction or clearance of serum or plasma HDV-RNA, after 12 months of treatment.

Secondary outcomes

Maintenance and Adherence to Therapy

Time frame: 12 months

Monitor patients' adherence to the bulevirtide treatment regimen, evaluating continuity of treatment and compliance with the prescribed dosage. This includes analysis of any interruptions or changes to treatment and the underlying reasons

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

Assessment of Response and Impact on Safety, Adherece Anc Persistent During Treatment in an Observational Trial for the Evaluation of the Long-term Effectiveness of Bulevirtide in Patients With Chronic Delta Hepatitis: the ARISTOTELE Study

Acronym: ARISTOTLE

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Aug 11, 2025
Registry last updated: Aug 11, 2025

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.