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Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

NCT01465516 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2015-06-30

No results posted yet for this study

Summary

Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.

Conditions

  • Hepatitis C Infection

Interventions

DRUG

Boceprevir

Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin). Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results

Sponsors & Collaborators

  • Arrowhead Regional Medical Center

    lead OTHER

Principal Investigators

  • Zeid Kayali, MD · Southern California Transplantation Institute Research Foundation

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465516 on ClinicalTrials.gov