Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00689390
Status:
TERMINATED
Last Update Posted:
2018-09-11
First Post:
2008-05-27
Brief Title:
Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C P05063
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Long-Term Follow-Up of Subjects in a Phase 1 2 or 3 Clinical Trial in Which Boceprevir or Narlaprevir Was Administered for the Treatment of Chronic Hepatitis C
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to satisfaction of post-marketing commitments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study P05063 is a 3-year long-term follow-up LTFU study in participants previously treated with boceprevir BOC or narlaprevir NAR in a Phase 1 2 or 3 clinical study Participants will be followed for up to 35 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response for sustained responders and to characterize the long-term safety after use of this therapeutic regimen LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid HCV-RNA by polymerase chain reaction PCR and HCV sequence analysis No drug therapy will be administered as part of this study
Detailed Description:
In Part 1 participants who previously participated in one of nine boceprevir studies P03523 NCT00423670 P03659 NCT00160251 P04487 No NCT P05101 NCT00708500 P05216 NCT00705432 P05411 NCT00959699 P05514 NCT00910624 P05685 NCT00845065 and P06086 NCT01023035 were followed for response In Part 2 participants who previously participated in one narlaprevir study P05104 NCT00797745 were followed for response
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 |
|---|---|---|---|
| 2006-006529-25 | EUDRACT_NUMBER | None | None |