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Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

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ClinicalTrials.gov Identifier: NCT01949077
Recruitment Status : Withdrawn
First Posted : September 24, 2013
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis C

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.
Study Start Date : December 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

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.



Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples Without DNA
Serum and tissue collected through the UNC Liver Center serum and tissue bank.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949077


Locations
United States, North Carolina
University of North Carolina Liver Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Michael W Fried, MD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01949077     History of Changes
Other Study ID Numbers: 11-2124
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by University of North Carolina, Chapel Hill:
Hepatitis
Hepatitis C
Observational study
Biomarkers of treatment response

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections