Last reviewed · How we verify
NCT07116044: ARISTOTLE
Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection
trial testing virological tests diagnostic tests in Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients in 160 participants. Completed in 30 July 2025.
1 June 2024
Quick facts
| Lead sponsor | University of Molise |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 160 |
| Start date | 15 June 2023 |
| Primary completion | 1 June 2024 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- virological tests diagnostic tests
Conditions studied
- Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients — all drugs for Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients →
Sponsor
University of Molise
Who can join
18 and older, any sex, with Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07116044
- Europe PMC full search
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- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07116044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Molise
- Last refreshed: 11 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07116044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing