Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment (LeeG3)
The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).
|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) that will be evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]Futility rules: HCV RNA ≥ 100 IU/mL at treatment week 12 or HCV RNA > the limit of detection (LoD) at treatment Week 24. If the HCV RNA is > LoD but < limit of quantification (LoQ), then the viral load test will be repeated within approximately 2 weeks. If the result from the repeat test is > LoD, futility is met and study therapy is discontinued.
- Evaluate SVR-12 measured 12 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 12. [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]Virologic breakthrough is defined as an initial undetectable HCV RNA reading at any time point during the study that subsequently becomes > LoQ while on therapy. If the HCV RNA is > LoQ and <1000 IU/mL, then the viral load test will be repeated within approximately 2 weeks. If the result from the repeat test is > LoQ, the definition of breakthrough is met and study therapy is discontinued.
- Viral resistance evaluations will be performed using archived plasma samples collected at pre-specified time points during the study. [ Time Frame: During 24 weeks of treatment and 24 weeks post treatment follow up ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||November 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|