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

NCT06397859 | Recruiting

• 1 other identifier: IN-IT-589-7118
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis D

Outcome Measures

Primary Outcomes (2)

• Investigate the virological response rate to BLV

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

  Week 96

• Investigate the virological response rate to BLV

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

  Week 96

Secondary Outcomes (7)

• 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

• Evaluation of the percentage of patients with normal ALT

  Week 96

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

  Week 96

• 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

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

  Week 96

Study Arms (1)

Hepatis Delta

Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously

Drug: Bulevirtide

Interventions

Bulevirtide DRUG

dose of 2 mg/day subcutaneously

Also known as: Hepcludex

Hepatis Delta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Chronic hepatitis without any evidence of cirrhosis
• Decompensated cirrhosis
• PegIFN alpha therapy

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

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

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Hepatitis D

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-04

Locations

IT (1)