Overview

This trial is active, not recruiting.

Condition hepatitis c
Sponsor University of North Carolina, Chapel Hill
Collaborator Merck Sharp & Dohme Corp.
Start date December 2011
End date December 2015
Trial size 60 participants
Trial identifier NCT01949077, 11-2124

Summary

The purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have significantly different levels of chemokines than responders.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients who achieve sustained virological response (SVR) are defined as undetectable HCV RNA in serum obtained 12 weeks or beyond the end of antiviral therapy.
Non-responders are defined as patients who have not achieved virological milestones during therapy or who have relapsed with detectable HCV RNA in serum after cessation of treatment.

Primary Outcomes

Measure
Level (ng/mL) of serum chemokines.
time frame: Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All adult patients (age 18 or older) treated with an antiviral Hepatitis C treatment regimen that includes Boceprevir. Exclusion Criteria: - Inability to provide informed consent for a serum sample enrolled in the University of North Carolina Liver Center serum bank. - No pre and post serum sample available within 6 months of the treatment period.

Additional Information

Official title Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.
Principal investigator Michael W Fried, MD
Description Patients undergoing standard of care at the UNC Liver Center are consented for collection of an additional serum sample under the UNC Liver Center serum and tissue bank study. These samples will be used to analyze differences in serum chemokines across responders and non-responders.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.