Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02204475
Status:
WITHDRAWN
Last Update Posted:
2015-10-14
First Post:
2014-07-28
Brief Title:
Grazoprevir MK-5172Elbasvir MK-8742 Versus BoceprevirPegylated InterferonRibavarin for Chronic Hepatitis C Infection MK-5172-066
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172MK-8742 Versus BoceprevirPegylated InterferonRibavirin PR in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection
Status:
WITHDRAWN
Status Verified Date:
2015-10
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:
This is a randomized multi-site open-label trial of a fixed-dose combination of Grazoprevir MK-5172 and Elbasvir MK-8742 versus Boceprevir BOC Pegylated Interferon P and Ribavirin R in treatment-naive and prior treatment failure genotype GT 1 hepatitis C virus HCV-infected participants The primary hypothesis is that the proportion of treatment-naive TN and prior treatment failure PTF participants treated with grazoprevir elbasvir achieving sustained virologic response undetectable HCV ribonucleic acid RNA 12 weeks after the end of study therapy SVR12 will be greater than the proportion of BOCPR-treated participants achieving SVR12
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-001841-25 | EUDRACT_NUMBER | None | None |