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

Hepatitis D Clinical Trial

— D-SHIELD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122285
• Other study ID #: 184853
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D

Intervention

Drug:
• Bulevirtide
dose of 2 mg/day subcutaneously

Locations

Country	Name	City	State
Italy	Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the virological response to BLV in all patients starting BLV therapy for CHD	Percentage of patients with undetectable HDV RNA	Month 6
Primary	Describe the virological response to BLV in all patients starting BLV therapy for CHD	Percentage of patients with = 2 log IU/ml decline of HDV RNA	Month 12
Secondary	Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA	Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA	Month 6
Secondary	Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA	Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA	Month 12
Secondary	Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA	Proportion of patients with virological response, defined as undetectable HDV-RNA	Month 6
Secondary	Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA	Proportion of patients with virological response, defined as undetectable HDV-RNA	Month 12
Secondary	Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT	Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT	Month 6
Secondary	Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT	Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT	Month 12
Secondary	Evaluation of the percentage of patients with normal ALT	Percentage of patients with normal ALT	Month 6
Secondary	Evaluation of the percentage of patients with normal ALT	Percentage of patients with normal ALT	Month 12
Secondary	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	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)	Month 6
Secondary	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	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)	Month 12
Secondary	Investigation of changes over time in serum levels of HBsAg (UI/mL)	Change in serum levels of HBsAg- by medians and ranges	Month 6
Secondary	Investigation of changes over time in serum levels of HBsAg (UI/mL)	Change in serum levels of HBsAg- by medians and ranges	Month 12
Secondary	Investigation of changes over time in serum levels of albumin (g/dL)	Change in serum levels albumin- by medians and ranges	Month 6
Secondary	Investigation of changes over time in serum levels of albumin (g/dL)	Change in serum levels albumin- by medians and ranges	Month 12
Secondary	Investigation of changes over time in serum levels of platelets (10e9/L)	Change in serum levels of platelets - by medians and ranges	Month 6
Secondary	Investigation of changes over time in serum levels of platelets (10e9/L)	Change in serum levels of platelets - by medians and ranges	Month 12
Secondary	Investigation of changes over time in serum levels of AFP (µg/L)	Change in serum levels of AFP - by medians and ranges	Month 6
Secondary	Investigation of changes over time in serum levels of AFP (µg/L)	Change in serum levels of AFP - by medians and ranges	Month 12
Secondary	Evaluation of treatment safety	Occurrence of change in serum bile acid levels (µmol/L)	Month 6
Secondary	Evaluation of treatment safety	Occurrence of adverse events	Month 6
Secondary	Evaluation of treatment safety	Occurrence of change in serum bile acid levels (µmol/L)	Month 12
Secondary	Evaluation of treatment safety	Occurrence of adverse events	Month 12