Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01405937
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2011-07-28
Brief Title:
Study of Vaniprevir Plus PegIntronRibavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment MK-7009-044
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety Tolerability and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment
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:
The purpose of this study is to evaluate the safety tolerability and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b PegIntronpeg-IFN and ribavirin RBV in chronic hepatitis C CHC Genotype I GT 1 participants who relapsed after previous therapy with interferon-based therapy The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy SVR24 in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20 historical data of standard of care treatment
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