Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03566966 |
Other study ID # |
Policlinic Hospital 3, Bari |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2015 |
Est. completion date |
March 31, 2017 |
Study information
Verified date |
December 2023 |
Source |
University of Bari |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.