Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01457937
Status:
UNKNOWN
Last Update Posted:
2012-10-02
First Post:
2011-10-08
Brief Title:
BoceprevirPegIFN α-2bRiba in HCV Gt1 Menopausal Women Nonresponders to PegIFNRiba or Treatment-naives MEN_BOC
Sponsor:
University of Modena and Reggio Emilia
Organization:
University of Modena and Reggio Emilia
Study Overview
Official Title:
BoceprevirPeginterferon Alfa PegIFN α-2bRibavirin Riba in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1 Gt 1 Either Deemed Nonresponders to PeginterferonRibavirin or Treatment-naives MEN_BOC
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEN_BOC
Brief Summary:
The cohort of post-menopausal women represents a group of very-difficult-to-treat patients in whom a more powerful approach is required in order to improve the disappointing response rate Thus the addition in patients with previous failure to PEGRBV treatment or in naïve patients of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by the results of SPRINT_2 trial in whom Boceprevir addition determined a 30 improvement in SVR rate in difficult gt 1 patients of African descent versus standard PEG IFNRibavirin therapy or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment with BocPR of previous failure of standard therapy
Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in patients difficult to treat such as HCV-positive women in post-menopausal women with genotype 1 not only those who have never been treated but also in those who have not responded to previous treatment with peginterferon and ribavirin Riba
Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in patients difficult to treat such as HCV-positive women in post-menopausal women with genotype 1 not only those who have never been treated but also in those who have not responded to previous treatment with peginterferon and ribavirin Riba
Detailed Description:
221 Hypothesis Our hypothesis is that the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of sustained virological response SVR in patients difficult to treat such as HCV-positive women in post-menopausal women with genotype 1 not only those who have never been treated but also in those who have not responded to previous treatment with peginterferon and ribavirin Riba Objectives Retreatment Primary objective Verify whether the sustained virological response SVR defined as HCV RNA undetectable at 24 weeks of follow-up in menopausal women with HCV CAH genotype 1 who have not achieved a sustained virological response with a previous treatment with PEG IFNribavirin may increase by at least 20 after treatment with PEG IFN alfa 2b and boceprevir 15 mcg kg QW Ribavirin 800-1400 mg day The primary efficacy endpoint achieving SVR will be evaluated with descriptive statistics n for each treatment arm
Secondary objective It is represented by evaluation of the percent of patients with early virological response undetectable HCV RNA at weeks 2 4 8 or 12 that reach SVR
Naïve patients
Primary objective Verify whether SVR defined as undetectable HCV-RNA at 24 weeks of follow-up may increase by at least 25 after treatment with PEG IFN alfa 2b plus ribavirin and boceprevir vs PEG IFN alfa 2b plus ribavirin alone in postmenopausal women with CHC genotype 1 not previously treated The primary efficacy endpoint achieving SVR will be evaluated with descriptive statistics n for each treatment arm
Secondary objective It is represented by evaluation of the percent of patients with early virological response undetectable HCV RNA at weeks 2 4 8 or 12 that reach SVR
Secondary objective It is represented by evaluation of the percent of patients with early virological response undetectable HCV RNA at weeks 2 4 8 or 12 that reach SVR
Naïve patients
Primary objective Verify whether SVR defined as undetectable HCV-RNA at 24 weeks of follow-up may increase by at least 25 after treatment with PEG IFN alfa 2b plus ribavirin and boceprevir vs PEG IFN alfa 2b plus ribavirin alone in postmenopausal women with CHC genotype 1 not previously treated The primary efficacy endpoint achieving SVR will be evaluated with descriptive statistics n for each treatment arm
Secondary objective It is represented by evaluation of the percent of patients with early virological response undetectable HCV RNA at weeks 2 4 8 or 12 that reach SVR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None