Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03222583
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2017-07-17
Brief Title:
A Study to Evaluate the Efficacy and Safety of GlecaprevirPibrentasvir ABT-493ABT-530 in Treatment-Naive and Treatment-Experienced Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype GT 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ABT-493ABT-530 in Treatment-Naïve and Treatment-Experienced Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype GT 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
Status:
COMPLETED
Status Verified Date:
2019-11
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:
VOYAGE-1
Brief Summary:
This study will evaluate the efficacy and safety of glecaprevirpibrentasvir ABT-493ABT-530 in non-cirrhotic chronic hepatitis C virus HCV genotype GT1 to GT6-infected Asian participants with or without human immunodeficiency virus HIV co-infection who are HCV treatment-naïve or treatment-experienced with interferon IFN with or without ribavirin RBV OR sofosbuvir with RBV with or without IFN
Detailed Description:
Randomization was stratified by geographic region China South Korea Singapore genotype GT1 GT2 combined GT3 - 6 and HCVHIV co-infection status co-infected not co-infected In China eligible participants were randomized to Arm A or Arm B defined below in the following ratios 21 for GT1 21 for GT2 and 21 for combined GT3-6 In South Korea and Singapore eligible participants were randomized to Arm A or Arm B in the following ratios 21 for GT1 and 21 for GT2
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None