Effektivitet och säkerhet för Bulevirtide (BLV)-terapi hos patienter med kronisk hepatitdelta (CHD) i Italien (D-SHIELD) (D-SHIELD)
Effektiviteten och säkerheten för Bulevirtide (BLV)-terapi hos patienter med kronisk hepatitdelta (CHD) i Italien: en multicenter prospektiv verklig datastudie
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.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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MI
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Milan, MI, Italien, 20122
- Rekrytering
- 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-post: pietro.lampertico@unimi.it
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Tidsram: Month 6
|
Percentage of patients with undetectable HDV RNA |
Month 6
|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Tidsram: Month 12
|
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA |
Month 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Tidsram: Month 6
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 6
|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Tidsram: Month 12
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 12
|
|
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Tidsram: Month 6
|
Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 6
|
|
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Tidsram: Month 12
|
Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 12
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Tidsram: Month 6
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 6
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Tidsram: Month 12
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 12
|
|
Evaluation of the percentage of patients with normal ALT
Tidsram: Month 6
|
Percentage of patients with normal ALT |
Month 6
|
|
Evaluation of the percentage of patients with normal ALT
Tidsram: Month 12
|
Percentage of patients with normal ALT |
Month 12
|
|
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
Tidsram: Month 6
|
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 6
|
|
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
Tidsram: Month 12
|
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 12
|
|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Tidsram: Month 6
|
Change in serum levels of HBsAg- by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Tidsram: Month 12
|
Change in serum levels of HBsAg- by medians and ranges |
Month 12
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|
Investigation of changes over time in serum levels of albumin (g/dL)
Tidsram: Month 6
|
Change in serum levels albumin- by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of albumin (g/dL)
Tidsram: Month 12
|
Change in serum levels albumin- by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
Tidsram: Month 6
|
Change in serum levels of platelets - by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
Tidsram: Month 12
|
Change in serum levels of platelets - by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
Tidsram: Month 6
|
Change in serum levels of AFP - by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
Tidsram: Month 12
|
Change in serum levels of AFP - by medians and ranges |
Month 12
|
|
Evaluation of treatment safety
Tidsram: Month 6
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 6
|
|
Evaluation of treatment safety
Tidsram: Month 6
|
Occurrence of adverse events |
Month 6
|
|
Evaluation of treatment safety
Tidsram: Month 12
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 12
|
|
Evaluation of treatment safety
Tidsram: Month 12
|
Occurrence of adverse events |
Month 12
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 184853
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