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

NCT ID: NCT07116044

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2025-07-30

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

virological tests diagnostic tests

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Molise

OTHER

Sponsor Role: lead

Responsible Party

Luca Rinaldi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università degli studi del molise

Campobasso, Seleziona, Italy

Countries

Italy

Other Identifiers

Gilead Sciences srl

Identifier Type: OTHER

Identifier Source: secondary_id

ARISTOTLE Research Project

Identifier Type: -

Identifier Source: org_study_id