Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment (LeeG3)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin|
- Sustained Virologic Response (SVR) at 24 Weeks Post Treatment [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
|Study Start Date:||May 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.
ii) Evaluate adverse events. iii) Evaluate viral resistance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585584
|University of Calgary Liver Unit|
|Calgary, Alberta, Canada, T2N 4Z6|
|Principal Investigator:||Samuel Lee, MD||University of Calgary|