ClinicalTrials.Veeva

Menu

Autoantibodies and Direct-acting Antivirals (BIOEPA)

U

University of Bari

Status

Completed

Conditions

Therapy Adverse Effect
Viral Hepatitis C

Treatments

Biological: Non-organ-specific Ab negative
Biological: Non-organ-specific Ab positive

Study type

Observational

Funder types

Other

Identifiers

NCT03566966
Policlinic Hospital 3, Bari

Details and patient eligibility

About

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.

Full 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.

Enrollment

191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

191 participants in 2 patient groups

Non-organ-specific Ab positive
Description:
Patients who had detectable circulating autoantibodies before treatment with antivirals.
Treatment:
Biological: Non-organ-specific Ab positive
Non-organ-specific Ab negative
Description:
Patients who did not have detectable circulating autoantibodies before treatment with antivirals.
Treatment:
Biological: Non-organ-specific Ab negative

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems