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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

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