An observational study in Hepatitis D, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.
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 retrospectively/longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, 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.
All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated 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.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's enrollment of 50 is below the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.
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All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated 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.
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Exclusion Criteria:
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
Drug: Bulevirtide
dose of 2 mg/day subcutaneously
Describe the virological response to BLV in all patients starting BLV therapy
percentage of patients with undetectable HDV RNA.
Time frame: Month 12
Describe the virological response to BLV in all patients starting BLV therapy
percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.
Time frame: Month 12
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment
Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT
Time frame: Month 12
Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment
Percentage of patients with normal ALT at 12 months of BLV treatment
Time frame: 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, at the end of the first year of treatment
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Time frame: Month 12
Evaluation of treatment safety
Occurrence change in serum bile acid levels (µmol/L)
Time frame: Month 12
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Apr 2023, 0 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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