A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

PHASE2CompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
CirrhosisHepatic Encephalopathy
Interventions
DRUG

HPN-100

Part B: 6 mL BID for 16 weeks.

DRUG

Placebo

Part B: same as experimental arm

Trial Locations (28)

10016

Concorde Medical Group PLLC, New York

NYU Medical Center, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center / Center for Liver Disease and Transplantation, New York

10595

New York Medical College / Westchester Medical Center, Valhalla

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland, Baltimore

22908

University of Virginia Health System, Charlottesville

33136

University of Miami / Center for Liver Diseases, Miami

33606

Tampa General Hospital, Tampa

37232

The Digestive Disease Center at Vanderbilt, Nashville

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati / Division of Digestive Diseases, Cincinnati

46202

Indiana University, Indianapolis

48202

Henry Ford Hospital / Department of Gastroenterology, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53792

University of Wisconsin Hospital & Clinics, Madison

60637

The University of Chicago Medical Center, Chicago

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Health Science Center, New Orleans

75203

Methodist Dallas Medical Center, Dallas

75390

UT Southwestern Medical Center, Dallas

77030

Baylor College of Medicine-St. Luke's Episcopal Hospital, Houston

94304

Stanford University Medical Center, Division of Gastroenterology and Hepatology, Palo Alto

03756

Dartmouth Hitchcock Medical Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY