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

Recruiting

• Conditions: Hepatitis D
• Interventions: Drug: Bulevirtide

• Registration Number: NCT06397859
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Study Start: 2024-05-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatis Delta	Bulevirtide	Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously

Primary Outcome Measures

Name	Time	Method
Investigate the virological response rate to BLV	Week 96	Percentage of patients with undetectable HDV-RNA (IU/mL)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA	Week 96	Percentage of patients with \< 1 log decline HDV RNA levels
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)	Week 96	Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT (combined response)
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.	Week 96	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;
Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response	Week 96	Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV
Evaluation of the percentage of patients with normal ALT	Week 96	Percentage of patients with normal ALT
Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)	Year 5	Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5
Evaluation of bile acids levels over time and correlation of bile levels with virological response rates	Week 96	Correlation between bile acids levels and virological response over time

Trial Locations

Locations (1)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.; 🇮🇹 Milano, Italy