Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis D
Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of
| Condition(s) | Hepatitis D |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a \>2 Log decline in HDV-RNA or undetectable HD |
| Who can participate | Inclusion Criteria: * 18 years of age or older * Chronic hepatitis delta * Compensated cirrhosis HDV related * Patients who will start therapy with BLV 2 mg/day from May 2023 Exclusion Criteria: * HDV-related decompensated cirrhosis (CPT ≥7) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Locations | Milan, MI, Italy |
| Start date | 2023-05-01 |
| NCT ID | NCT06122285 |
| Official listing | https://clinicaltrials.gov/study/NCT06122285 |