Evaluating bulevirtide therapy for chronic hepatitis D in Greece
Hellenic Multicenter Real-life Clinical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV
This study is testing how well bulevirtide therapy works for adults with chronic hepatitis D in Greece to see if it can help manage their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 80 Years |
| Sex | All |
| Sponsor | University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT05928000 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the efficacy and safety of bulevirtide (BLV) therapy in patients with chronic hepatitis D across various liver centers in Greece. It aims to address the underdiagnosis of hepatitis D virus (HDV) infection and the challenges in managing patients who are co-infected with hepatitis B virus (HBV). The study includes adult patients who have started BLV treatment prior to the study protocol approval, allowing for a real-world evaluation of treatment outcomes. The research highlights the importance of proper management of HDV to prevent severe liver complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 16 years old with chronic hepatitis D who have begun bulevirtide treatment.
Not a fit: Patients who started bulevirtide treatment after the study protocol began will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with chronic hepatitis D, potentially reducing the risk of severe liver disease.
How similar studies have performed: While this approach is novel in the context of real-life clinical settings for bulevirtide therapy, similar studies have shown promise in evaluating antiviral treatments for hepatitis infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult (\>16 years old) patients with chronic hepatitis D followed at any of the participating centers * Start of BLV treatment before the approval of the study protocol. * Any patient with or without concomitant use of a nucleos(t)ide analogue. Patients with concomitant use of pegylated interferon-alfa can be included. Exclusion Criteria: * Any patient with chronic hepatitis D who started BLV after the start of the study protocol
Where this trial is running
Athens
- Department of Gastroenterology, Medical School of National & Kapodistrian University of Athens, General Hospital of Athens "Laiko"; — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: George Papatheodoridis, MD
- Email: gepapath@med.uoa.gr
- Phone: +306946330639
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.