Actively Recruiting
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-01-10
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of chronic hepatitis delta
- Compensated cirrhosis related to HDV
- Patients starting Bulevirtide 2 mg/day therapy from May 2023
You will not qualify if you...
- Decompensated cirrhosis related to HDV (Child-Pugh score 7 or higher)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, MI, Italy, 20122
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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