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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.


Recruitment information / eligibility

Status Completed
Enrollment 191
Est. completion date March 31, 2017
Est. primary completion date August 31, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy. Exclusion Criteria: History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.

Study Design


Intervention

Biological:
Non-organ-specific Ab positive
Antiviral administration and evaluation of SVR24 and side effects
Non-organ-specific Ab negative
direct-acting antiviral agents

Locations

Country Name City State
Italy Policlinic Hospital Bari

Sponsors (1)

Lead Sponsor Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sustained virological response Evaluation of HCV-RNA levels 24 weeks after the end of antiviral therapy
Secondary Disappearance of non-organ-specific antibodies Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies 24 weeks after the end of antiviral therapy
Secondary Side effects Clinical manifestations and laboratory alterations 24 weeks after the end of antiviral therapy
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