Completed

Phase 2
Age: 18Years - 75Years
All Genders
ID01966419

Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)

Led by Ocera Therapeutics, Inc. · Updated on 2021-09-16

231

Participants Needed

131

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
  • Elevated venous ammonia
Not Eligible

You will not qualify if you...

  • Renal failure with serum creatinine > 3 mg/dL or need for dialysis
  • Molecular Adsorbent Recirculation System utilized
  • Pregnancy or breastfeeding

Trial Site Locations

Total: 131 locations

1

Phoenix, Arizona, United States, 85006

Status Unknown

2

Phoenix, Arizona, United States, 85054

Status Unknown

3

Little Rock, Arkansas, United States, 72205

Status Unknown

4

Coronado, California, United States, 92118

Status Unknown

5

Los Angeles, California, United States, 90033

Status Unknown

6

Los Angeles, California, United States, 90048

Status Unknown

7

San Francisco, California, United States, 94115

Status Unknown

8

San Francisco, California, United States, 94143

Status Unknown

9

New Haven, Connecticut, United States, 06504

Status Unknown

10

Miami, Florida, United States, 33136

Status Unknown

11

Atlanta, Georgia, United States, 30309

Status Unknown

12

Atlanta, Georgia, United States, 30322

Status Unknown

13

Chicago, Illinois, United States, 60611

Status Unknown

14

Chicago, Illinois, United States, 60612

Status Unknown

15

Chicago, Illinois, United States, 60637

Status Unknown

16

Glenview, Illinois, United States, 60026

Status Unknown

17

Iowa City, Iowa, United States, 52242

Status Unknown

18

Iowa City, Iowa, United States, 52246

Status Unknown

19

New Orleans, Louisiana, United States, 70112

Status Unknown

20

New Orleans, Louisiana, United States, 70121

Status Unknown

21

Baltimore, Maryland, United States, 21201

Status Unknown

22

Baltimore, Maryland, United States, 21287

Status Unknown

23

Bethesda, Maryland, United States, 20814

Status Unknown

24

Boston, Massachusetts, United States, 02114

Status Unknown

25

Boston, Massachusetts, United States, 02215

Status Unknown

26

Minneapolis, Minnesota, United States, 55455

Status Unknown

27

Jackson, Mississippi, United States, 39216

Status Unknown

28

Columbia, Missouri, United States, 65212

Status Unknown

29

Newark, New Jersey, United States, 07103

Status Unknown

30

Buffalo, New York, United States, 14215

Status Unknown

31

New York, New York, United States, 10029

Status Unknown

32

New York, New York, United States, 10032

Status Unknown

33

Chapel Hill, North Carolina, United States, 27514

Status Unknown

34

Columbus, Ohio, United States, 43210

Status Unknown

35

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

36

Philadelphia, Pennsylvania, United States, 19107

Status Unknown

37

Philadelphia, Pennsylvania, United States, 19141

Status Unknown

38

Pittsburgh, Pennsylvania, United States, 15213

Status Unknown

39

Charleston, South Carolina, United States, 29425

Status Unknown

40

Nashville, Tennessee, United States, 37232

Status Unknown

41

Dallas, Texas, United States, 75203

Status Unknown

42

Dallas, Texas, United States, 75235

Status Unknown

43

Dallas, Texas, United States, 75246

Status Unknown

44

Dallas, Texas, United States, 75390

Status Unknown

45

Houston, Texas, United States, 77030

Status Unknown

46

Richmond, Virginia, United States, 23249

Status Unknown

47

Seattle, Washington, United States, 98104

Status Unknown

48

Seattle, Washington, United States, 98195

Status Unknown

49

Milwaukee, Wisconsin, United States, 53226

Status Unknown

50

Kingswood, New South Wales, Australia, 2747

Status Unknown

51

Adelaide, South Australia, Australia, 5000

Status Unknown

52

Bedford Park, South Australia, Australia, 5042

Status Unknown

53

Melbourne, Victoria, Australia, 3004

Status Unknown

54

Melbourne, Australia, 3065

Status Unknown

55

Parkville, Australia, 3050

Status Unknown

56

Graz, Austria, 8036

Status Unknown

57

Vienna, Austria, 1090

Status Unknown

58

Vienna, Austria, 1160

Status Unknown

59

Brussels, Belgium, 1020

Status Unknown

60

Brussels, Belgium, 1070

Status Unknown

61

Brussels, Belgium, 1200

Status Unknown

62

Ghent, Belgium, 9000

Status Unknown

63

Leuven, Belgium, 3000

Status Unknown

64

Sofia, Bulgaria, 1431

Status Unknown

65

Sofia, Bulgaria, 1606

Status Unknown

66

Brno, Czechia, 625 00

Status Unknown

67

Prague, Czechia, 14021

Status Unknown

68

Ústí nad Labem, Czechia, 401 13

Status Unknown

69

Aarhus, Denmark, 8000

Status Unknown

70

Copenhagen, Denmark, 2100

Status Unknown

71

Esbjerg, Denmark, 6700

Status Unknown

72

Hvidovre, Denmark, 2650

Status Unknown

73

Tartu, Estonia, 51014

Status Unknown

74

Bordeaux, France, 33000

Status Unknown

75

Grenoble, France, 38043

Status Unknown

76

La Roche, France, 85925

Status Unknown

77

Lille, France, 59037

Status Unknown

78

Lyon, France, 69317

Status Unknown

79

Nice, France, 06200

Status Unknown

80

Paris, France, 75651

Status Unknown

81

Pessac, France, 33604

Status Unknown

82

Toulouse, France, 31053

Status Unknown

83

Villejuif, France, 94800

Status Unknown

84

Hanover, Niedersachesen, Germany, D-30625

Status Unknown

85

Bonn, Germany, 53127

Status Unknown

86

Freiburg im Breisgau, Germany, 79106

Status Unknown

87

Halle, Germany, 06120

Status Unknown

88

Hamburg, Germany, 20246

Status Unknown

89

Heidelberg, Germany, 69120

Status Unknown

90

Leipzig, Germany, 04103

Status Unknown

91

Mainz, Germany, 55131

Status Unknown

92

Debrecen, Hungary, 4031

Status Unknown

93

Gyula, Hungary, 5700

Status Unknown

94

Kaposvár, Hungary, 7400

Status Unknown

95

Pécs, Hungary, 7624

Status Unknown

96

Haifa, Israel, 3109601

Status Unknown

97

Haifa, Israel, 3436212

Status Unknown

98

Jerusalem, Israel, 9112001

Status Unknown

99

Petah Tikva, Israel, 49372

Status Unknown

100

Ramat Gan, Israel, 49372

Status Unknown

101

Safed, Israel, 13100

Status Unknown

102

Tel Aviv, Israel, 64239

Status Unknown

103

Bergamo, Italy, 24127

Status Unknown

104

Bologna, Italy, 40138

Status Unknown

105

Florence, Italy, 50134

Status Unknown

106

Milan, Italy, 20122

Status Unknown

107

Palermo, Italy, 90141

Status Unknown

108

Roma, Italy, 00161

Status Unknown

109

Rozzano, Italy, 20089

Status Unknown

110

San Giovanni Rotondo, Italy, 71013

Status Unknown

111

Leiden, Netherlands, 2333 ZA

Status Unknown

112

Maastricht, Netherlands, 6229 HX

Status Unknown

113

Auckland, New Zealand, 1142

Status Unknown

114

Moscow, Russia, 111123

Status Unknown

115

Moscow, Russia, 117198

Status Unknown

116

Moscow, Russia, 119992

Status Unknown

117

Moscow, Russia, 129090

Status Unknown

118

Samara, Russia, 443011

Status Unknown

119

A Coruña, Spain, 15706

Status Unknown

120

Barcelona, Spain, 08035

Status Unknown

121

Barcelona, Spain, 08036

Status Unknown

122

Barcelona, Spain, 08041

Status Unknown

123

Girona, Spain, 17007

Status Unknown

124

Madrid, Spain, 28007

Status Unknown

125

Madrid, Spain, 28034

Status Unknown

126

Madrid, Spain, 28222

Status Unknown

127

Málaga, Spain, 29010

Status Unknown

128

Pontevedra, Spain, 36071

Status Unknown

129

Santander, Spain, 39008

Status Unknown

130

Seville, Spain, 41014

Status Unknown

131

Valencia, Spain, 46026

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes.

Rifaat Safadi, Robert S Rahimi, Dominique Thabut...

https://pubmed.ncbi.nlm.nih.gov/35238476

Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial.

Robert S Rahimi, Rifaat Safadi, Dominique Thabut...

https://pubmed.ncbi.nlm.nih.gov/33069881