Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06397859

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatitis D Digestive System Diseases Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Milan, 20122, Italy

Location status: Recruiting

Location contact

Pietro Lampertico, MD

CONTACT

[email protected]

0255035432

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bulevirtide

Drug

dose of 2 mg/day subcutaneously

Other names: Hepcludex

Primary outcomes

  1. Investigate the virological response rate to BLV

    Time frame: Week 96

    Percentage of patients with >2 Log decline in HDV-RNA (IU/mL)

  2. Investigate the virological response rate to BLV

    Time frame: Week 96

    Percentage of patients with undetectable HDV-RNA (IU/mL)

Secondary outcomes

  1. 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)

    Time frame: Week 96

    Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT (combined response)

  2. Evaluation of the percentage of patients with normal ALT

    Time frame: Week 96

    Percentage of patients with normal ALT

  3. Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA

    Time frame: Week 96

    Percentage of patients with < 1 log decline HDV RNA levels

  4. 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.

    Time frame: Week 96

    Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;

  5. Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response

    Time frame: Week 96

    Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV

  6. Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)

    Time frame: Year 5

    Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5

  7. Evaluation of bile acids levels over time and correlation of bile levels with virological response rates

    Time frame: Week 96

    Correlation between bile acids levels and virological response over time

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: SAVE-D

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 3, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.