A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

PHASE3CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

October 11, 2010

Primary Completion Date

February 28, 2013

Study Completion Date

May 10, 2013

Conditions
Hepatorenal Syndrome
Interventions
DRUG

Terlipressin

Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution.

DRUG

Placebo

11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution.

Trial Locations (73)

10016

Bellevue Hospital, New York

NYU Langhorn Medical Center, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center, New York

10595

New York Medical College/Westchester Medical Center, Valhalla

15240

VA Pittsburgh Healthcare System, Pittsburgh

19102

Drexel University College of Medicine, Philadelphia

19104

University of Pennsylvania, Philadelphia

19140

Temple University Hospital, Philadelphia

19141

Albert Einstein Medical Center, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland, Baltimore

23249

McGuire DVAMC, Richmond

23298

Virginia Commonwealth University Health System, Richmond

28203

Carolinas Medical Center, Charlotte

29209

WJB Dorn VA Medical Center, Columbia

30322

Emory University Hospital, Atlanta

32224

Mayo Clinic, Jacksonville

33136

University of Miami, Miami

35294

University of Alabama at Birmingham, Birmingham

37212

Vanderbilt Medical Center, Nashville

40202

University of Louisville, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati, Internal Medicine-Digestive Diseases, Cincinnati

46202

Indiana University Health - University Hospital, Indianapolis

48202

Henry Ford Hospital, Detroit

52246

Iowa City VA Health Care System, Iowa City

53792

University of Wisconsin, Madison

55414

University of Minnesota, Minneapolis

60153

Loyola University Medical Center, Maywood

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

63110

Saint Louis University, St Louis

Washington University School of Medicine, St Louis

64111

Saint Luke's Hospital, Kansas City

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

70112

Tulane Medical Center, New Orleans

73112

INTEGRIS Baptist Medical Center, Oklahoma City

75216

Dallas VA Medical Center, Dallas

75246

Baylor University Medical Center, Dallas

75390

UT Southwestern Medical Center, Dallas

76104

Baylor All Saints Medical Center, Fort Worth

77030

St. Luke's Advanced Liver Therapies, Houston

The Methodist Hospital, Houston

University of Texas Health Science Center at Houston - Memorial Hermann Hospital, Houston

77555

The University of Texas Medical Branch at Galveston, Galveston

78229

Methodist Specialty Transplant Hospital Lab, San Antonio

The University of Texas Health Science Center at San Antonio, San Antonio

University of Texas Health Science Center, San Antonio

80045

University of Colorado Denver, Aurora

84132

University of Utah, Salt Lake City

85006

Banner Good Samaritan Medical Center/Liver Disease Center, Phoenix

85054

Mayo Clinic Arizona, Phoenix

85713

University of Arizona Medical Center South Campus, Tucson

85724

University of Arizona Liver Research Institute, Tucson

90033

USC University Hospital, Los Angeles

92037

Scripps Clinic, La Jolla

92118

SCTI Research Foundation, Coronado

92161

Veteran's Administration Medical Center, San Diego

92324

Arrowhead Regional Medical Center, Colton

94115

California Pacific Medical Center, San Francisco

95817

UC Davis Medical Center, Sacramento

97239

Orgeon Health & Science University, Portland

98101

Virginia Mason Medical Center, Seattle

06102

Hartford Hospital, Hartford

06520

Yale University School of Medicine, New Haven

02215

Beth Lsrael Deaconess Medical Center, Boston

01805

Lahey Clinic Medical Center, Burlington

01655

University of Massachusetts Medical Center, Worcester

M5G 2C4

Toronto General Hospital, Toronto

H2X 3J4

CHUM, Hopital St-Luc, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY