Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01390844
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2011-07-07
Brief Title:
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 P07063
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin
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:
This study will assess the efficacy of boceprevir BOC in combination with PegIntron pegylated interferon alfa-2b PEG and ribavirin RBV in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C CHC genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen BOCPEGRBV is superior to that in the control arm PlaceboPEGRBV in the Full Analysis Set FAS population
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 |
|---|---|---|---|
| CTRI201204002540 | REGISTRY | CTRI | None |
| 2007-005151-42 | EUDRACT_NUMBER | None | None |
| 3034-033 | OTHER | None | None |