Effektivitet og kliniske resultater af langvarig Bulevirtide monoterapi hos patienter med HDV-relateret kompenseret cirrhosis (SAVE-D)
Effektivitet og kliniske resultater af langvarig Bulevirtid-monoterapi hos patienter med HDV-relateret kompenseret cirrose (SAVE-D-undersøgelse)
Retrospective and prospective, pharmacological, multicentre, non-profit observational study.
Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.
Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.
Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Milan, Italien, 20122
- Rekruttering
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Kontakt:
- Pietro Lampertico, MD
- Telefonnummer: 0255035432
- E-mail: pietro.lampertico@unimi.it
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start 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 meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.
Beskrivelse
Inclusion Criteria:
- Age≥18 years
- HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
- Started treatment with BLV monotherapy between September 1st 2019 and 2025
Exclusion Criteria:
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
- PegIFN alpha therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Investigate the virological response rate to BLV
Tidsramme: Week 96
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Percentage of patients with >2 Log decline in HDV-RNA (IU/mL) |
Week 96
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Investigate the virological response rate to BLV
Tidsramme: Week 96
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Percentage of patients with undetectable HDV-RNA (IU/mL) |
Week 96
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)
Tidsramme: Week 96
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Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT (combined response) |
Week 96
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Evaluation of the percentage of patients with normal ALT
Tidsramme: Week 96
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Percentage of patients with normal ALT |
Week 96
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Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
Tidsramme: Week 96
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Percentage of patients with < 1 log decline HDV RNA levels |
Week 96
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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 week 96 of treatment.
Tidsramme: Week 96
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96; |
Week 96
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Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response
Tidsramme: Week 96
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Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV |
Week 96
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Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)
Tidsramme: Year 5
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Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5 |
Year 5
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Evaluation of bile acids levels over time and correlation of bile levels with virological response rates
Tidsramme: Week 96
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Correlation between bile acids levels and virological response over time |
Week 96
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IN-IT-589-7118
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