Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
- Registration Number
- NCT06122285
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- HDV-related decompensated cirrhosis (CPT ≥7)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hepatis Delta Bulevirtide Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
- Primary Outcome Measures
Name Time Method Describe the virological response to BLV in all patients starting BLV therapy for CHD Month 12 Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
- Secondary Outcome Measures
Name Time Method Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA Month 12 Proportion of patients with virological response, defined as a \>2 Log decline in HDV-RNA
Investigation of changes over time in serum levels of AFP (µg/L) Month 12 Change in serum levels of AFP - by medians and ranges
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT Month 12 Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT
Investigation of changes over time in serum levels of HBsAg (UI/mL) Month 12 Change in serum levels of HBsAg- by medians and ranges
Investigation of changes over time in serum levels of platelets (10e9/L) Month 12 Change in serum levels of platelets - by medians and ranges
Investigation of changes over time in serum levels of albumin (g/dL) Month 12 Change in serum levels albumin- by medians and ranges
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA Month 12 Proportion of patients with virological response, defined as undetectable HDV-RNA
Evaluation of the percentage of patients with normal ALT Month 12 Percentage of patients with normal ALT
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 Month 12 Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Evaluation of treatment safety Month 12 Occurrence of adverse events
Trial Locations
- Locations (1)
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
🇮🇹Milan, MI, Italy