Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01949077

Enrollment

Registered

2013-09-24

Start date

2011-12-31

Completion date

2016-01-31

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis, Hepatitis C, Observational study, Biomarkers of treatment response

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results