Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00910624
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2009-05-28
Brief Title:
Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to PeginterferonRibavirin P05514
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Single-Arm Study to Provide Boceprevir Treatment in Subjects With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to PeginterferonRibavirin in Previous Schering-Plough Boceprevir Studies
Status:
COMPLETED
Status Verified Date:
2021-01
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:
PROVIDE
Brief Summary:
This is a single-arm multicenter study of boceprevir BOC in combination with peginterferon plus ribavirin PEGRBV in adult chronic hepatitis C CHC genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response SVR while in the PEGRBV control arms of an Schering-Plough Research Institute SPRI study of BOC combination therapy Participants who are able to enroll in this study within 2 weeks after the last dose of PEGRBV in previous protocol are to receive BOC PEGRBV for up to 44 weeks followed by 24 weeks post-treatment follow-up Participants who are not able to enroll in this study within 2 weeks after the last dose of PEGRBV in previous protocol are to receive PEGRBV for 4 weeks followed by BOC PEGRBV for up to 44 weeks with 24 weeks post-treatment follow-up
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