35
Participants
Start Date
September 1, 2012
Primary Completion Date
April 30, 2019
Study Completion Date
April 30, 2020
Carbaglu
"Carbaglu Chemical Composition: N-carbamoyl-L-glutamic acid (NCG)~The daily dose will be 150 mg/kg/ day or 3.3 g/m2/day for patients \>15 kg and will be administered for 7 days or until discharge, whichever is sooner. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube. Standard of care will prevail when choosing the mode of drug administration.~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast-push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste."
Placebo
Placebo that looks/tastes the same as NCG and is administered on the same schedule as the NCG intervention
Mount Sinai School of Medicine, New York
University of Pittsburgh, Pittsburgh
The Children's Hospital of Philadelphia (CHOP), Philadelphia
Children's National Medical Center, Washington D.C.
University Hospitals Cleveland Medical Center, Cleveland
The Children's Hospital of Colorado, Aurora
University of California Los Angeles, Los Angeles
Lucile Packard Children's Hospital at Stanford, Palo Alto
Children's Hospital Boston, Boston
Collaborators (1)
Children's National Research Institute
OTHER
Boston Children's Hospital
OTHER
University Hospitals Cleveland Medical Center
OTHER
University of California, Los Angeles
OTHER
Children's Hospital of Philadelphia
OTHER
Stanford University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Pittsburgh
OTHER
Children's Hospital Colorado
OTHER
Mendel Tuchman
OTHER