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Recruiting NCT06122285

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

— Observational Hepatitis D

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bulevirtide.
Who it may be relevant to
Registry conditions: Hepatitis D. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study

Overview

Multicenter pharmacological observational prospective, no-profit, study. 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 longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, 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. HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.

Interventions

  • Drug Bulevirtide
    dose of 2 mg/day subcutaneously

Primary outcome measures

  • Describe the virological response to BLV in all patients starting BLV therapy for CHD [Time frame: Month 6]
  • Describe the virological response to BLV in all patients starting BLV therapy for CHD [Time frame: Month 12]
Secondary outcome measures (12)
  • Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA [Time frame: Month 6]
  • Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA [Time frame: Month 12]
  • Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA [Time frame: Month 6]
  • Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA [Time frame: Month 12]
  • Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT [Time frame: Month 6]
  • Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT [Time frame: Month 12]
  • Evaluation of the percentage of patients with normal ALT [Time frame: Month 6]
  • Evaluation of the percentage of patients with normal ALT [Time frame: Month 12]
  • 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 [Time frame: Month 6]
  • 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 [Time frame: Month 12]
  • Investigation of changes over time in serum levels of HBsAg (UI/mL) [Time frame: Month 6]
  • Investigation of changes over time in serum levels of HBsAg (UI/mL) [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

  • 18 years of age or older
  • Chronic hepatitis delta
  • Compensated cirrhosis HDV related
  • Patients who will start therapy with BLV 2 mg/day from May 2023

Exclusion criteria

  • HDV-related decompensated cirrhosis (CPT ≥7)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology an — Milan

Identifiers

NCT: NCT06122285 · 184853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗