Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02806362
Status:
WITHDRAWN
Last Update Posted:
2016-12-05
First Post:
2016-06-16
Brief Title:
Study of OmbitasvirParitaprevirRitonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus HCV Infection With End Stage Renal Disease ESRD on Hemodialysis HD
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
An Open-Label Study to Evaluate the Safety and Efficacy of OmbitasvirParitaprevirRitonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus HCV Infection With End Stage Renal Disease on Hemodialysis GIFT-R
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely prior to enrollment of first participant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFT-R
Brief Summary:
The purpose of this multicenter single-arm combination-drug study which includes 12 weeks of treatment and 24 weeks of follow-up is to evaluate the safety efficacy and pharmacokinetics of ombitasvirparitaprevirritonavir in Japanese adults infected with HCV GT1b who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD
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