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NCT01949077 Clinical Trial

Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Hepatitis C Clinical Trial

Official title:
Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01949077
Other study ID # 11-2124
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 2011
Est. completion date January 2016

Study information
Verified date November 2017
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of North Carolina Liver Center Chapel Hill North Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level (ng/mL) of serum chemokines. 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). Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose
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