Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06122285

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

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.

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, MI, 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

  • 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)

Treatment and study plan

Bulevirtide

Drug

dose of 2 mg/day subcutaneously

Primary outcomes

  1. Describe the virological response to BLV in all patients starting BLV therapy for CHD

    Time frame: Month 6

    Percentage of patients with undetectable HDV RNA

  2. Describe the virological response to BLV in all patients starting BLV therapy for CHD

    Time frame: Month 12

    Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA

Secondary outcomes

  1. Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

    Time frame: Month 6

    Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

  2. Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

    Time frame: Month 12

    Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA

  3. Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA

    Time frame: Month 6

    Proportion of patients with virological response, defined as undetectable HDV-RNA

  4. Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA

    Time frame: Month 12

    Proportion of patients with virological response, defined as undetectable HDV-RNA

  5. Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT

    Time frame: Month 6

    Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT

  6. Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT

    Time frame: Month 12

    Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT

  7. Evaluation of the percentage of patients with normal ALT

    Time frame: Month 6

    Percentage of patients with normal ALT

  8. Evaluation of the percentage of patients with normal ALT

    Time frame: Month 12

    Percentage of patients with normal ALT

  9. 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

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

  10. 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

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

  11. Investigation of changes over time in serum levels of HBsAg (UI/mL)

    Time frame: Month 6

    Change in serum levels of HBsAg- by medians and ranges

  12. Investigation of changes over time in serum levels of HBsAg (UI/mL)

    Time frame: Month 12

    Change in serum levels of HBsAg- by medians and ranges

  13. Investigation of changes over time in serum levels of albumin (g/dL)

    Time frame: Month 6

    Change in serum levels albumin- by medians and ranges

  14. Investigation of changes over time in serum levels of albumin (g/dL)

    Time frame: Month 12

    Change in serum levels albumin- by medians and ranges

  15. Investigation of changes over time in serum levels of platelets (10e9/L)

    Time frame: Month 6

    Change in serum levels of platelets - by medians and ranges

  16. Investigation of changes over time in serum levels of platelets (10e9/L)

    Time frame: Month 12

    Change in serum levels of platelets - by medians and ranges

  17. Investigation of changes over time in serum levels of AFP (µg/L)

    Time frame: Month 6

    Change in serum levels of AFP - by medians and ranges

  18. Investigation of changes over time in serum levels of AFP (µg/L)

    Time frame: Month 12

    Change in serum levels of AFP - by medians and ranges

  19. Evaluation of treatment safety

    Time frame: Month 6

    Occurrence of change in serum bile acid levels (µmol/L)

  20. Evaluation of treatment safety

    Time frame: Month 6

    Occurrence of adverse events

  21. Evaluation of treatment safety

    Time frame: Month 12

    Occurrence of change in serum bile acid levels (µmol/L)

  22. Evaluation of treatment safety

    Time frame: Month 12

    Occurrence of adverse events

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: D-SHIELD

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Jan 10, 2025

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.