Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160251
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2005-09-08
Brief Title:
Boceprevir SCH 503034 Plus Peg-Intron With and Without Added Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin Study P03659AM2COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
PEG-IntronREBETOL vs PEG-Intron SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 HCV-1 Peginterferon AlfaRibavirin Nonresponders A SCH 503034 Dose-Finding Phase 2 Study
Status:
COMPLETED
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:
The primary objective of this study is to determine the safe and effective dose range of boceprevir SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir
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