Long-term treatment with Bulevirtide for patients with Hepatitis D-related cirrhosis
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
This study is testing if a medication called Bulevirtide can help people with Hepatitis D-related cirrhosis improve their health over a long period of time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06397859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with HDV-related compensated cirrhosis who have started Bulevirtide treatment.
Not a fit: Patients with decompensated cirrhosis or chronic hepatitis without evidence of cirrhosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from Hepatitis D-related compensated cirrhosis.
How similar studies have performed: While this approach is relatively novel, there is ongoing interest in the effectiveness of Bulevirtide for treating Hepatitis D, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. — Milan, 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.