47
Participants
Start Date
June 30, 2012
Primary Completion Date
February 23, 2017
Study Completion Date
February 23, 2017
Ornithine Phenylacetate
"Up to 36 patients will be enrolled into 2 groups \[\~18 with minimal renal dysfunction (Cohort 1) \& \~18 w/ comprised renal function (Cohort 2)\] and receive OCR-002 infusion for at least 72 hrs. OCR-002 will be administered in the vein and pharmacokinetics (pk) assessed for all subjects who receive the infusion.~The first 24 enrolled subjects received OCR-002 at 3 ascending dose levels (DLs 1-3) with a maximum target infusion rate equivalent to 10g/24h.~The remaining 12 patients (\~6 Cohort 1 \& \~6 Cohort 2) will be enrolled and receive identical quantities of OCR-002 at 20g/24hr continuously for 5 days (Dose Level 4)."
Virginia Commonwealth University, Richmond
Medical University of South Carolina, Charleston
Emory University, Atlanta
The Ohio State University, Columbus
University of Michigan Medical Center, Ann Arbor
Northwestern University, Chicago
University of Kansas Medical Center, Kansas City
University of Texas Southwestern Medical Center, Dallas
University of California, San Francisco, San Francisco
University of Washington, Seattle
Yale University School of Medicine, New Haven
Collaborators (1)
Medical University of South Carolina
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Ocera Therapeutics
INDUSTRY
William Lee
OTHER