An observational study in Viral Hepatitis C and Therapy Adverse Effect, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of Bari · Observational
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 191 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of Bari is the lead sponsor of 75 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Caucasian patients affected by chronic hepatitis C virus infection who were consecutively admitted as outpatients to the Gastroenterology Unit, Policlinic Hospital, Bari, Italy, from July 2015-August 2016 to receive a treatment with second generation direct-acting antivirals.
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.
Patients who had detectable circulating autoantibodies before treatment with antivirals.
Biological: Non-organ-specific Ab positive
Patients who did not have detectable circulating autoantibodies before treatment with antivirals.
Biological: Non-organ-specific Ab negative
Antiviral administration and evaluation of SVR24 and side effects
Also known as: direct-acting antiviral agents
direct-acting antiviral agents
Sustained virological response
Evaluation of HCV-RNA levels
Time frame: 24 weeks after the end of antiviral therapy
Disappearance of non-organ-specific antibodies
Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies
Time frame: 24 weeks after the end of antiviral therapy
Side effects
Clinical manifestations and laboratory alterations
Time frame: 24 weeks after the end of antiviral therapy
Plan to share: Undecided — It depends on the possibility to merge similar data and produce a multicentric study
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Bari