Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423670
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2007-01-17
Brief Title:
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 Study P03523
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Status:
COMPLETED
Status Verified Date:
2017-03
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 was an open-label randomized safety and efficacy trial in adult treatment-naïve Chronic Hepatitis C CHC participants with genotype 1 infection The study conducted in 2 parts compared standard-of-care PegIntron 15 μgkg once weekly QW plus ribavirin 800 to 1400 mgday for 48 weeks to five treatment paradigms containing boceprevir SCH 503034 800 mg thrice a day TID The five treatments included boceprevir BOC plus standard-of-care for 28 or 48 weeks with and without a 4-week lead-in with PegIntron PEG and ribavirin RBV and exploration of PegIntron plus low-dose ribavirin 400 to 1000 mgday plus boceprevir for 48 weeks
Detailed Description:
The study was conducted in 2 parts
Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mgday and compared
PegIntron and ribavirin for 48 weeks Arm 1 - Control
PegIntron ribavirin and boceprevir for 28 weeks Arm 2
Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron ribavirin and boceprevir for 24 weeks Arm 3
PegIntron ribavirin and boceprevir for 48 weeks Arm 4
Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron ribavirin and boceprevir for 44 weeks Arm 5
Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm Arm 8
Part 2 of the study assessed the safety and efficacy of low dose ribavirin 400-1000 mgday and compared
PegIntron ribavirin 800-1400 mgday and boceprevir for 48 weeks Arm 6
PegIntron low-dose ribavirin 400-1000 mgday and boceprevir for 48 weeks Arm 7
Follow-up for all participants was up to 72 weeks after randomization
Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mgday and compared
PegIntron and ribavirin for 48 weeks Arm 1 - Control
PegIntron ribavirin and boceprevir for 28 weeks Arm 2
Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron ribavirin and boceprevir for 24 weeks Arm 3
PegIntron ribavirin and boceprevir for 48 weeks Arm 4
Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron ribavirin and boceprevir for 44 weeks Arm 5
Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm Arm 8
Part 2 of the study assessed the safety and efficacy of low dose ribavirin 400-1000 mgday and compared
PegIntron ribavirin 800-1400 mgday and boceprevir for 48 weeks Arm 6
PegIntron low-dose ribavirin 400-1000 mgday and boceprevir for 48 weeks Arm 7
Follow-up for all participants was up to 72 weeks after randomization
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 |
|---|---|---|---|
| EudraCT No 2006-002543-92 | None | None | None |