Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Withdrawn

• Conditions: Hepatitis C

• Registration Number: NCT01949077
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-11
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level (ng/mL) of serum chemokines.	Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose	Compare levels of serum chemokines across Boceprevir responders (SVR) and non-responders for both Baseline (\<=6-months pre-treatment) and Post-treatment (\<=6-months post-treatment).

Trial Locations

Locations (1)

University of North Carolina Liver Center; 🇺🇸 Chapel Hill, North Carolina, United States