Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01544920
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2012-02-28
Brief Title:
Safety and Efficacy of BoceprevirPeginterferon Alfa-2aRibavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus HCV Genotype 1 Participants P07755
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Safety and Efficacy Study of BoceprevirPeginterferon Alfa-2aRibavirin in Chronic HCV Genotype 1 IL28B CC Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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 purpose of this study is to compare the efficacy of two boceprevir BOC-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus HCV genotype 1 who have the IL28B CC allele
The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid RNA at the end of the peginterferon alfa-2a peg-IFN plus ribavirin RBV 4 week lead-in Participants receive either peg-IFN RBV Arm 1 or BOC peg-IFN RBV Arm 2 The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up FU Week 24
The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid RNA at the end of the peginterferon alfa-2a peg-IFN plus ribavirin RBV 4 week lead-in Participants receive either peg-IFN RBV Arm 1 or BOC peg-IFN RBV Arm 2 The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up FU Week 24
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 |
|---|---|---|---|
| PHRR131022-000133 | REGISTRY | PHRR | None |
| 2011-001345-32 | EUDRACT_NUMBER | None | None |
| MK-3034-040 | OTHER | None | None |
| CTRI201212003200 | REGISTRY | None | None |