Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962307
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-03-21
Brief Title:
Efficacy and Safety of Bulevirtide BLV Therapy in HDV Chronic Hepatitis CHD in Italy
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Efficacy and Safety of Bulevirtide BLV Therapy in HDV Chronic Hepatitis CHD Patients in Italy a National Real Life Data Study
Status:
COMPLETED
Status Verified Date:
2023-03
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:
HEP4Di
Brief Summary:
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 patients 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 retrospectivelylongitudinally
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 20 quantitative kit LLQ 6 IUml at month 12 of therapy
All patients with active HDV chronic hepatopathy quantifiable HDV-RNA who initiated treatment with BLV 2 mgday during the study period at the SC 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
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 patients 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 retrospectivelylongitudinally
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 20 quantitative kit LLQ 6 IUml at month 12 of therapy
All patients with active HDV chronic hepatopathy quantifiable HDV-RNA who initiated treatment with BLV 2 mgday during the study period at the SC 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
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?:
True
Is an FDA AA801 Violation?:
None