Long-term treatment with Bulevirtide for patients with Hepatitis D-related cirrhosis

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 evaluate the effectiveness and clinical outcomes of Bulevirtide monotherapy in patients with HDV-related compensated cirrhosis. It will enroll consecutive patients starting treatment with Bulevirtide 2 mg/day from September 2019 to December 2025, assessing both retrospective and prospective data. The primary endpoint is the rate of virological response, defined as at least a 2 Log decline or undetectable HDV RNA compared to baseline, measured at week 96 of treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥18 years
* HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
* Started treatment with BLV monotherapy between September 1st 2019 and 2025

Exclusion Criteria:

* Chronic hepatitis without any evidence of cirrhosis
* Decompensated cirrhosis
* PegIFN alpha therapy

Where it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effect of Bulevirtide on Chronic Hepatitis Delta in Italy

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• Observational study on Hepatitis D patients in France

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• Evaluation of patients with liver disease

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  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT00001971

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.