48
Participants
Start Date
October 31, 2011
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
Ornithine-phenylacetate
"Phase A: Open-label scalating dose of OP. Treatment will be initiated at 1/3 of the final dose and will be scalated every 12 hours up to the full dose, except if there are problems of tolerance. Duration of the infusion 5 days.~Phase B: Comparative study of experimental drug vs placebo for 5 days OP (OCR-002) at a dose of 10 g diluted in 150 ml of water for injection administered as a continuous i.v. infusion for 24 hours (8.3 ml/h)during 5 days."
Hospital Vall Hebron, Barcelona
Hospital Universitari Vall d'Hebron Research Institute
OTHER