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โ† Trials
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Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Poโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 patien

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ7)
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What it tests

  • Bulevirtide
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Where

1 site
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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