3
Participants
Start Date
February 5, 2015
Primary Completion Date
July 15, 2015
Study Completion Date
July 15, 2015
Kedbumin 25%
"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
Normal Saline Solution
Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.
Kosair Charities Pediatric Unit, Louisville
Medical College of Wisconsin, Milwaukee
Collaborators (1)
inVentiv Health Clinical
OTHER
Kedrion S.p.A.
INDUSTRY