A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders

PHASE4CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

October 17, 2016

Study Completion Date

July 17, 2017

Conditions
Urea Cycle Disorder
Interventions
DRUG

RAVICTI

Trial Locations (17)

10029

Mount Sinai School of Medicine, New York

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

30033

Emory University, Decatur

32610

Shands at University of Florida, Gainesville

44106

University Hospitals Case Medical Center, Cleveland

46202

Indiana University, Indianapolis

48201

Children's Hospital of Michigan, Detroit

55455

University of Minnesota, Minneapolis

84132

University of Utah, Salt Lake City

90027

Kaiser Permanente Regional Metabolic Center, Los Angeles

94034

Stanford Center for Clinical & Translational Research & Education, Palo Alto

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

04102

Maine Medical Center, Portland

M5G 1Hs

The Hospital for Sick Children, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY