Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104052
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2005-02-22
Brief Title:
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C Study P02538 Part 1
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Assessment of the Safety Efficacy Tolerability and Pharmacokinetics of PEG-Intron Plus REBETOL in Pediatric Patients With Chronic Hepatitis C
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:
The primary objective is to assess the safety efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C
Detailed Description:
This global multicenter open-label Phase 3 study will evaluate the safety efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects ages 3 through 17 years with chronic hepatitis C
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