Effect of Bulevirtide on Chronic Hepatitis Delta in Italy
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06122285
This study is testing if the medication Bulevirtide can help people with Chronic Hepatitis Delta in Italy feel better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06122285 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of Bulevirtide (BLV) therapy in patients with Chronic Hepatitis Delta (CHD) across multiple hepatology centers in Italy. It follows EASL 2017 guidelines to ensure uniformity in antiviral treatment and management. Data will be collected longitudinally from patients at various time points during the treatment period, focusing on virological response defined by a significant decline in HDV-RNA levels. The study will not use off-label medications and will rely on data from patients' medical records.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with compensated cirrhosis related to Chronic Hepatitis Delta who are starting BLV therapy.
Not a fit: Patients with HDV-related decompensated cirrhosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Bulevirtide therapy for patients with Chronic Hepatitis Delta.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating antiviral therapies for hepatitis conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Milan, MI
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. — Milan, MI, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatitis D