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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Includes incidence of severe oral mucositis (OM), duration of severe OM, Patient-reported outcome (PRO) daily assessments of mouth and throat soreness, use of parenteral or transdermal opioid analgesics
Up to Day 28
No
MD
Study Director
Amgen
United States: Food and Drug Administration
20040212
NCT00109031
January 2005
December 2010
Name | Location |
---|