Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

Completed

• Conditions: Hepatitis D
• Interventions: Drug: Bulevirtide

• Registration Number: NCT05962307
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.

This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected retrospectively/longitudinally.

The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, defined as a \>2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ \<6 IU/ml) at month 12 of therapy.

All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated treatment with 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 met the inclusion criteria and none of the exclusion criteria.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-21
• Study Start: 2023-04-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-31
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years of age or older
• Chronic hepatitis delta
• Compensated cirrhosis HDV related
• Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022

Exclusion Criteria

• HDV-related decompensated cirrhosis (CPT ≥7)

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
Describe the virological response to BLV in all patients starting BLV therapy	Month 12	percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Evaluation of treatment safety	Month 12	Occurrence change in serum bile acid levels (µmol/L)
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment	Month 12	Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT
Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment	Month 12	Percentage of patients with normal ALT at 12 months of BLV treatment
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 the end of the first year of treatment	Month 12	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)

Trial Locations

Locations (1)

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