Autoantibodies and Direct-acting Antivirals

NCT03566966 | Completed

• 1 other identifier: Policlinic Hospital 3, Bari
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Viral Hepatitis C; Therapy Adverse Effect

Keywords

hepatitis C virus infection; non-organ-specific antibodies; prognostic value; sustained virological response

Outcome Measures

Primary Outcomes (1)

• Sustained virological response

  Evaluation of HCV-RNA levels

  24 weeks after the end of antiviral therapy

Secondary Outcomes (2)

• Disappearance of non-organ-specific antibodies

  24 weeks after the end of antiviral therapy

• Side effects

  24 weeks after the end of antiviral therapy

Study Arms (2)

Non-organ-specific Ab positive

Patients who had detectable circulating autoantibodies before treatment with antivirals.

Biological: Non-organ-specific Ab positive

Non-organ-specific Ab negative

Patients who did not have detectable circulating autoantibodies before treatment with antivirals.

Biological: Non-organ-specific Ab negative

Interventions

Non-organ-specific Ab positive BIOLOGICAL

Antiviral administration and evaluation of SVR24 and side effects

Also known as: direct-acting antiviral agents

Non-organ-specific Ab positive

Non-organ-specific Ab negative BIOLOGICAL

direct-acting antiviral agents

Non-organ-specific Ab negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.

You may not qualify if:

• History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Policlinic Hospital

Bari, 70124, Italy

Location

Related Publications (1)

• Shahini E, Iannone A, Romagno D, Armandi A, Carparelli S, Principi M, Viggiani MT, Ierardi E, Di Leo A, Barone M. Clinical relevance of serum non-organ-specific antibodies in patients with HCV infection receiving direct-acting antiviral therapy. Aliment Pharmacol Ther. 2018 Nov;48(10):1138-1145. doi: 10.1111/apt.14999.

  PMID: 30375693 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for antibodies determination

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Alfredo Di Leo, MD, PhD

  University of Bari

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 25, 2018
• Study Start: July 1, 2015
• Primary Completion: August 31, 2016
• Study Completion: March 31, 2017
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

IT (1)