Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

NCT01949077 | Withdrawn

• 1 other identifier: 11-2124
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• All adult patients (age 18 or older) treated with an antiviral Hepatitis C treatment regimen that includes Boceprevir.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of North Carolina Liver Center

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and tissue collected through the UNC Liver Center serum and tissue bank.

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• Michael W Fried, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 24, 2013
• Study Start: December 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 30, 2023

Record last verified: 2017-11

Locations

US (1)