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

Hepatitis D Clinical Trial

— HEP4Di  

Official title:

Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05962307
• Other study ID #: IN-IT-589-6246
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: May 31, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 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

• Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022

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	percentage of patients with undetectable HDV RNA.	Month 12
Primary	Describe the virological response to BLV in all patients starting BLV therapy	percentage of patients with = 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.	Month 12
Secondary	Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment	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, at the twelfth month of treatment	Percentage of patients with normal ALT at 12 months of BLV treatment	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, at the end of the first year of treatment	Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)	Month 12
Secondary	Evaluation of treatment safety	Occurrence change in serum bile acid levels (µmol/L)	Month 12