Autoantibodies and Direct-acting Antivirals

Viral Hepatitis C Clinical Trial

— BIOEPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566966
• Other study ID #: Policlinic Hospital 3, Bari
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Therapy Adverse Effect
• Viral Hepatitis C

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