Clinical trial NCT06122285: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with CHD (quantifiable HDV-RNA) who will start 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: 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.


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)

Primary outcomes:
measure: Describe the virological response to BLV in all patients starting BLV therapy for CHD
timeFrame: Month 6
measure: Describe the virological response to BLV in all patients starting BLV therapy for CHD
timeFrame: Month 12
Secondary outcomes:
measure: Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
timeFrame: Month 6
measure: Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
timeFrame: Month 12
measure: Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
timeFrame: Month 6
measure: Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
timeFrame: Month 12
measure: Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
timeFrame: Month 6
measure: Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
timeFrame: Month 12
measure: Evaluation of the percentage of patients with normal ALT
timeFrame: Month 6
measure: Evaluation of the percentage of patients with normal ALT
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
timeFrame: Month 6
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
timeFrame: Month 12
measure: Investigation of changes over time in serum levels of HBsAg (UI/mL)
timeFrame: Month 6
measure: Investigation of changes over time in serum levels of HBsAg (UI/mL)
timeFrame: Month 12
measure: Investigation of changes over time in serum levels of albumin (g/dL)
timeFrame: Month 6
measure: Investigation of changes over time in serum levels of albumin (g/dL)
timeFrame: Month 12
measure: Investigation of changes over time in serum levels of platelets (10e9/L)
timeFrame: Month 6
measure: Investigation of changes over time in serum levels of platelets (10e9/L)
timeFrame: Month 12
measure: Investigation of changes over time in serum levels of AFP (µg/L)
timeFrame: Month 6
measure: Investigation of changes over time in serum levels of AFP (µg/L)
timeFrame: Month 12
measure: Evaluation of treatment safety
timeFrame: Month 6
measure: Evaluation of treatment safety
timeFrame: Month 6
measure: Evaluation of treatment safety
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: