Effect of Bulevirtide on Chronic Hepatitis Delta in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
  Milan, Mi, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.