Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02023112
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2013-12-23
Brief Title:
Study to Evaluate the Efficacy and Safety of ABT-450RitonavirABT- 267 ABT-450rABT-267 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus HCV Infection
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
An Open-label Study to Evaluate the Efficacy and Safety of ABT-450RitonavirABT-267 ABT-450rABT-267 Co-administered With Ribavirin RBV for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus HCV Infection With and Without Compensated Cirrhosis GIFT-II
Status:
COMPLETED
Status Verified Date:
2021-07
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:
GIFT-II
Brief Summary:
This is a Phase 3 randomized open-label multicenter study enrolling non-cirrhotic and cirrhotic subjects The purpose of this study is to evaluate the efficacy and safety of ABT-450rABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon IFN treatment-experienced subjects with and without compensated cirrhosis
Detailed Description:
None
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