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OpenTrials
Completed

NCT Number: NCT03566966

Autoantibodies and Direct-acting Antivirals

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.

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Key information

Conditions

Viral Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Therapy Adverse Effect Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinic Hospital

Bari, 70124, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-organ-specific Ab positive

Biological

Antiviral administration and evaluation of SVR24 and side effects

Other names: direct-acting antiviral agents

Non-organ-specific Ab negative

Biological

direct-acting antiviral agents

Primary outcomes

  1. Sustained virological response

    Time frame: 24 weeks after the end of antiviral therapy

    Evaluation of HCV-RNA levels

Secondary outcomes

  1. Disappearance of non-organ-specific antibodies

    Time frame: 24 weeks after the end of antiviral therapy

    Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies

  2. Side effects

    Time frame: 24 weeks after the end of antiviral therapy

    Clinical manifestations and laboratory alterations

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy

Acronym: BIOEPA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 25, 2018
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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