Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Hepatitis D Clinical Trial

— SAVE-D  

Official title:

Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397859
• Other study ID #: IN-IT-589-7118
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective and prospective, pharmacological, multicentre, non-profit observational study.

Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.

Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.

Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: August 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis D

Intervention

Drug:
• Bulevirtide
dose of 2 mg/day subcutaneously

Locations

Country	Name	City	State
Italy	Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the virological response rate to BLV	Percentage of patients with >2 Log decline in HDV-RNA (IU/mL)	Week 96
Primary	Investigate the virological response rate to BLV	Percentage of patients with undetectable HDV-RNA (IU/mL)	Week 96
Secondary	Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)	Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT (combined response)	Week 96
Secondary	Evaluation of the percentage of patients with normal ALT	Percentage of patients with normal ALT	Week 96
Secondary	Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA	Percentage of patients with < 1 log decline HDV RNA levels	Week 96
Secondary	Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;	Week 96
Secondary	Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response	Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV	Week 96
Secondary	Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)	Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5	Year 5
Secondary	Evaluation of bile acids levels over time and correlation of bile levels with virological response rates	Correlation between bile acids levels and virological response over time	Week 96