Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01718145
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2012-10-29
Brief Title:
A Phase 3 Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase 3 Comparative Study of Asunaprevir and Daclatasvir DUAL Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject
The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir ASV and Daclatasvir DCV to Telaprevir TVR included therapy in Japanese Hepatitis C virus HCV subjects
The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir ASV and Daclatasvir DCV to Telaprevir TVR included therapy in Japanese Hepatitis C virus HCV subjects
Detailed Description:
Intervention Model Parallel in the Naive cohort and Single group in the Relapser cohort
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