Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00457418
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2007-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Pharmacokinetic Study of PEG-Intron, Administered Weekly in Subjects With High-Risk Melanoma
Status:
COMPLETED
Status Verified Date:
2017-05
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 purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: