Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment (LeeG3)
|ClinicalTrials.gov Identifier: NCT01585584|
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Boceprevir||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||July 2015|
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).
- Sustained Virologic Response (SVR) at 24 Weeks Post Treatment [ Time Frame: 24 weeks after treatment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585584
|University of Calgary Liver Unit|
|Calgary, Alberta, Canada, T2N 4Z6|
|Principal Investigator:||Samuel Lee, MD||University of Calgary|