NCT07116044

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: University of Molise · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-06-01
• Completion: 2025-07-30
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: Italy