Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

October 26, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Liver Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including Boceprevir).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sustained virological response
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Michael W Fried, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimated)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe