Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

NCT02532907 | Completed

• 2 other identifiers: 14-1794UL1TR001082
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood. The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.

Conditions

Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

• Changes in gene array from baseline to either 4 or 12 weeks after treatment.

  To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.

  1 year

Study Arms (2)

Patients who will have their second Liver biopsy at week 4

The 4 week time point is performed in lieu of the 12 week and the purpose of this time point is to evaluate earlier responses and transcriptional changes that might predict viral clearance or treatment failure in a subset of patients.

Procedure: Liver Biopsy

Patients who will have their second Liver biopsy at week 12

Liver biopsies will be obtained at week 12 when most DAA treatments end in order to compare the hepatic responses induced or reduced by clearance of HCV

Procedure: Liver Biopsy

Interventions

Liver Biopsy PROCEDURE

patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.

Patients who will have their second Liver biopsy at week 12; Patients who will have their second Liver biopsy at week 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruitment of patients will primarily occur through the Hepatology clinic, so non-veterans will be recruited. A total of 20 HCV-positive patients who will be treated with FDA-approved treatments as covered by the patient's insurance. Half of the patients will be treatment-naïve prior to enrollment and half will be treatment-experienced with either null response or relapse, i.e., persistent viremia. An equal proportion in each group will be biopsied at 4 versus 12 weeks after first dosing of DAA. Patients will be subjected to two biopsies during the life of the study.

You may qualify if:

• Signed informed consent
• Ages 18-70
• HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.

You may not qualify if:

• Pregnant women or females of childbearing potential that are not on contraception
• Institutionalized or mentally disabled persons
• Prisoners
• Unwilling or unable to provide informed consent
• Subjects who are HIV positive
• Anticipated inability to follow up
• Chronic anemia
• Platelet count \< 100 for liver biopsy patients who have documented fatty liver disease by ultrasound prior to enrollment
• Any patient with bleeding disorders or prolonged INR
• Abstinent or consuming less than two drinks of alcohol per day.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Sandra Boimbo

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Golden-Mason L, Palmer B, Klarquist J, Mengshol JA, Castelblanco N, Rosen HR. Upregulation of PD-1 expression on circulating and intrahepatic hepatitis C virus-specific CD8+ T cells associated with reversible immune dysfunction. J Virol. 2007 Sep;81(17):9249-58. doi: 10.1128/JVI.00409-07. Epub 2007 Jun 13.

  PMID: 17567698 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Some of the data, blood and tissue that is taken during the study will be kept and used in future research to learn more about \_Hepatitis C.

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

• Hugo Rosen, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: July 10, 2018
• Study Completion: July 10, 2018
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

US (1)