Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109031
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2005-04-22
Brief Title:
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation PROMISE
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Randomized Blinded Active-control Trial of Palifermin rHuKGF to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation fTBI and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell PBPC Transplantation
Status:
COMPLETED
Status Verified Date:
2014-09
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:
To evaluate whether palifermin rHuKGF administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis World Health Organization WHO grade 3 and 4
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