NCT01966419 - Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE) | Biotech Hunter

Enrollment

231

Participants

Timeline

Start Date

January 7, 2014

Primary Completion Date

December 29, 2016

Study Completion Date

December 29, 2016

Conditions

Acute Episode of Overt Hepatic EncephalopathyHepatic Encephalopathy

Interventions

DRUG

ornithine phenylacetate

Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation

DRUG

placebo intravenous infusion

Placebo for continuous IV infusion that is visually identical to the experimental product

Trial Locations (131)

1020

Brussels

1070

Brussels

1090

Vienna

1142

Auckland

1160

Vienna

1200

Brussels

1431

Sofia

1606

Sofia

2100

Copenhagen

2650

Hvidovre

2747

Kingswood

3000

Leuven

3004

Melbourne

3050

Parkville

3065

Melbourne

4031

Debrecen

5000

Adelaide

5042

Bedford Park

5700

Gyula

6700

Esbjerg

7400

Kaposvár

7624

Pécs

8000

Aarhus

8036

Graz

9000

Ghent

10029

New York

10032

New York

13100

Safed

14021

Prague

14215

Buffalo

15213

Pittsburgh

15706

A Coruña

17007

Girona

19104

Philadelphia

19107

Philadelphia

19141

Philadelphia

20089

Rozzano

20122

Milan

20246

Hamburg

20814

Bethesda

21201

Baltimore

21287

Baltimore

23249

Richmond

24127

Bergamo

27514

Chapel Hill

28007

Madrid

28034

Madrid

28222

Madrid

29010

Málaga

29425

Charleston

30309

Atlanta

30322

Atlanta

31053

Toulouse

33000

Bordeaux

33136

Miami

33604

Pessac

36071

Pontevedra

37232

Nashville

38043

Grenoble

39008

Santander

39216

Jackson

40138

Bologna

41014

Seville

43210

Columbus

46026

Valencia

49372

Petah Tikva

Ramat Gan

50134

Florence

51014

Tartu

52242

Iowa City

52246

Iowa City

53127

Bonn

53226

Milwaukee

55131

Mainz

55455

Minneapolis

59037

Lille

60026

Glenview

60611

Chicago

60612

Chicago

60637

Chicago

64239

Tel Aviv

65212

Columbia

69120

Heidelberg

69317

Lyon

70112

New Orleans

70121

New Orleans

71013

San Giovanni Rotondo

72205

Little Rock

75203

Dallas

75235

Dallas

75246

Dallas

75390

Dallas

75651

Paris

77030

Houston

79106

Freiburg im Breisgau

85006

Phoenix

85054

Phoenix

85925

La Roche

90033

Los Angeles

90048

Los Angeles

90141

Palermo

92118

Coronado

94115

San Francisco

94143

San Francisco

94800

Villejuif

98104

Seattle

98195

Seattle

111123

Moscow

117198

Moscow

119992

Moscow

129090

Moscow

443011

Samara

3109601

Haifa

3436212

Haifa

9112001

Jerusalem

06504

New Haven

02114

Boston

02215

Boston

07103

Newark

625 00

Brno

401 13

Ústí nad Labem

06200

Nice

D-30625

Hanover

06120

Halle

04103

Leipzig

00161

Roma

2333 ZA

Leiden

6229 HX

Maastricht

08035

Barcelona

08036

Barcelona

08041

Barcelona