Clinical trial NCT06397859: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Official title: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.

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.


Eligibility 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

Primary outcomes:
measure: Investigate the virological response rate to BLV
timeFrame: Week 96
measure: Investigate the virological response rate to BLV
timeFrame: Week 96
Secondary outcomes:
measure: 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)
timeFrame: Week 96
measure: Evaluation of the percentage of patients with normal ALT
timeFrame: Week 96
measure: Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
timeFrame: Week 96
measure: 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.
timeFrame: Week 96
measure: Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response
timeFrame: Week 96
measure: Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)
timeFrame: Year 5
measure: Evaluation of bile acids levels over time and correlation of bile levels with virological response rates
timeFrame: Week 96
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Study officials:
References: