Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397859
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-30
Brief Title:
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis SAVE-D Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE-D
Brief Summary:
Retrospective and prospective pharmacological multicentre non-profit observational study
Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mgday 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 mgday 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
Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mgday 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 mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None