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

University of Molise

Status: Completed

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

Treatments: Diagnostic Test: virological tests diagnostic tests

Study type: Observational

Funder types: Other

Identifiers

NCT07116044

ARISTOTLE Research Project

Gilead Sciences srl (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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