Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504485
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection Outcomes and Response to Bulevirtide Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection Association With Disease Outcomes and Response to Bulevirtide Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPR_BD
Brief Summary:
Pharmacological single-center non-profit observational study
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy the University of Milan the University of Parma and Rome Tor Vergata funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call Prot P2022WEXP2
Hepatitis D virus HDV is a defective RNA virus which requires the presence of hepatitis B virus HBV to infect liver cells and propagate To date the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood as is the course of the HDV-specific immune response CD4 and CD8 T cells As in chronic HBV and HCV infections the outcome of chronic HDV infection appears to be dictated primarily by the host immune response which represents a key determinant for virus control or persistence For HBVHDV coinfection the role of T cells has not been well defined as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped mainly limited to HLA-B alleles
The study is divided into two substudies cross-sectional and longitudinal The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline pre-treatment
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy the University of Milan the University of Parma and Rome Tor Vergata funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call Prot P2022WEXP2
Hepatitis D virus HDV is a defective RNA virus which requires the presence of hepatitis B virus HBV to infect liver cells and propagate To date the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood as is the course of the HDV-specific immune response CD4 and CD8 T cells As in chronic HBV and HCV infections the outcome of chronic HDV infection appears to be dictated primarily by the host immune response which represents a key determinant for virus control or persistence For HBVHDV coinfection the role of T cells has not been well defined as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped mainly limited to HLA-B alleles
The study is divided into two substudies cross-sectional and longitudinal The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline pre-treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None