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| ID | Type | Description | Link |
|---|---|---|---|
| Gilead Sciences srl | Other Identifier | Università degli Studi del Molise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virological tests diagnostic tests | Diagnostic Test | The parameters collected will include blood sugar, HbA1c, complete blood count, lipid profile (total cholesterol, LDL, HDL, triglycerides), liver profile (ALT, AST, total and fractionated bilirubin, alkaline phosphatase, GGT) and renal profile (creatinine, azotemia), electrophoretic protein picture. Additionally, specific data for HDV and HBV infection will be collected, including HBsAg, anti-HBs, anti-HBc, HBV-DNA, and HDV-RNA. The glomerular filtration rate shall be calculated using the formula CKD-EPI. • Instrumental Tests: Results of abdominal ultrasounds, Fibroscan®/CAP for the evaluation of liver fibrosis |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of bulevirtide | Evaluate the virological response to treatment with bulevirtide, measured as reduction or clearance of serum or plasma HDV-RNA, after 12 months of treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance and Adherence to Therapy | Monitor patients' adherence to the bulevirtide treatment regimen, evaluating continuity of treatment and compliance with the prescribed dosage. This includes analysis of any interruptions or changes to treatment and the underlying reasons | 12 months |
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Inclusion Criteria:
Patients with HDV and HBV-related liver disease considered suitable for antiviral or immunomodulatory treatment.
Exclusion Criteria:
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Patients with HDV and HBV-related liver disease considered suitable for antiviral or immunomodulatory treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli studi del molise | Campobasso | Seleziona | 86100 | Italy |
e-identified individual ATIs (raw or derived) of study participants
Additional documentation (protocol, statistical analysis plan, data dictionary
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