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

NCT02532907 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2018-09-19

No results posted yet for this study

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

Interventions

PROCEDURE

Liver Biopsy

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Hugo Rosen, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-07-10
Completion
2018-07-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532907 on ClinicalTrials.gov