Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00704184
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2008-06-23
Brief Title:
Safety and Efficacy of Vaniprevir MK7009 Administered With Pegylated-Interferon and Ribavirin MK-7009-007
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase II Randomized Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
Status:
COMPLETED
Status Verified Date:
2018-09
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:
A study to evaluate how effective different levels of Vaniprevir MK-7009 when administered with Pegylated-Interferon Peg-IFN and Ribavirin are at achieving rapid viral response RVR ie undetectable hepatitis C virus HCV viral ribonucleic acid RNA at Week 4 in participants with chronic HCV infection The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFNRibavirin
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 |
|---|---|---|---|
| 2007_658 | None | None | None |
| MK7009-007 | None | None | None |