Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-02 @ 2:01 AM
Study NCT ID:
NCT03566966
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibodies and Direct-acting Antivirals
Sponsor:
University of Bari
Organization:
Study Overview
Official Title:
Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy
Status:
COMPLETED
Status Verified Date:
2023-12
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:
BIOEPA
Brief Summary:
The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value.
To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.
To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.
Detailed Description:
About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects.
Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.
Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.
Study Oversight
Has Oversight DMC:
False
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?: