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

NCT07116044 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-08-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Molise

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2024-06-01
Completion
2025-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116044 on ClinicalTrials.gov