Clinical trial NCT05962307: Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy
Official title: Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis D
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Describe the virological response to BLV in all patients starting BLV therapy
timeFrame: Month 12
measure: Describe the virological response to BLV in all patients starting BLV therapy
timeFrame: Month 12
Secondary outcomes:
measure: Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment
timeFrame: Month 12
measure: Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment
timeFrame: Month 12
measure: 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
timeFrame: Month 12
measure: Evaluation of treatment safety
timeFrame: Month 12
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
state: MI
Study officials:
References: