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

NCT07116044 | Completed DMC

• 2 other identifiers: ARISTOTLE Research ProjectGilead Sciences srl
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The study is non-interventional, multicenter, non-profit
2. 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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of bulevirtide

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

  12 months

Secondary Outcomes (1)

• Maintenance and Adherence to Therapy

  12 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Molise: lead

Study Sites (1)

Università degli studi del molise

Campobasso, Seleziona, 86100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: June 15, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)