Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06822790

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Led by Arrowhead Pharmaceuticals · Updated on 2026-05-08

869

Participants Needed

248

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.

CONDITIONS

Official Title

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults, male or nonpregnant, nonlactating females able and willing to provide written informed consent
  • Completed all required visits in the parent study protocol
  • Female participants of childbearing potential agree to use effective contraception during the study and for 90 days after last plozasiran dose
  • Male participants agree to use condoms during the study and for 90 days after last plozasiran dose
  • No sperm or egg donation during the study and for 90 days after last plozasiran dose
  • Female subjects on hormonal contraceptives stable for more than one menstrual cycle prior to Day 1
  • On standard of care lipid and triglyceride-lowering medications unless intolerant as determined by investigator
  • Participants with history of atherosclerotic cardiovascular disease or elevated 10-year ASCVD risk must be on appropriate lipid-lowering therapy
  • Participants with diabetes must be on optimized antidiabetic regimen and have no recent severe diabetic complications or hospitalizations within 24 weeks prior to Day 1
  • Willingness to follow diet counseling and maintain a stable low-fat diet
  • Participants from USA and Canada who completed AROAPOC3-2003 with HbA1c ≤10% within 30 days prior to Day 1
  • Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 with specified baseline fasting triglyceride levels and history of acute pancreatitis as per protocol
  • Participants who met eligibility for AROAPOC3-3003 or AROAPOC3-3004 but were not randomized, meeting all other criteria and HbA1c ≤10% within 30 days of Day 1
Not Eligible

You will not qualify if you...

  • Permanently discontinued plozasiran in the parent study due to elevated liver enzymes or unresponsive HbA1c elevation
  • Withdrew consent for continued study treatment in the parent study
  • Known hypersensitivity to plozasiran or its components
  • Any new or worsening condition deemed unsuitable by the investigator or that interferes with study participation
  • Unwilling to limit alcohol consumption to moderate levels during the study
  • Poorly controlled blood sugar with HbA1c >10% prior to Day 1
  • Acute pancreatitis within 4 weeks prior to Day 1
  • Use of hepatocyte-targeted siRNA or antisense oligonucleotides targeting lipids/triglycerides within specified timeframes prior to Day 1
  • Use of investigational agents or devices other than plozasiran within 30 days prior to Day 1
  • Recent unstable or symptomatic cardiac arrhythmia within 90 days prior to Day 1 (stable well-controlled atrial arrhythmias allowed)
  • Uncontrolled hypertension at Day 1 (systolic >160 mmHg or diastolic >100 mmHg) unless controlled before re-evaluation
  • Other exclusion criteria may apply per protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 248 locations

1

Research Site 21

Bakersfield, California, United States, 93311

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2

Research Site 9

Beverly Hills, California, United States, 90211

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3

Research Site 11

Canoga Park, California, United States, 91303

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4

Research Site 40

Garden Grove, California, United States, 92844

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5

Research Site 235

Huntington Beach, California, United States, 92648

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6

Research Site 236

Lake Forest, California, United States, 92630

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7

Research Site 39

Lincoln, California, United States, 95648

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8

Research Site 34

Oxnard, California, United States, 93030

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9

Research Site 229

Palm Springs, California, United States, 92262

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10

Research Site 155

Fort Lauderdale, Florida, United States, 33308

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11

Research Site 14

Hialeah, Florida, United States, 33016

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12

Research Site 154

Miami, Florida, United States, 33144

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13

Research Site 1

Miami Lakes, Florida, United States, 33014

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14

Research Site 162

Mt. Dora, Florida, United States, 32757

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15

Research Site 42

Mt. Dora, Florida, United States, 32757

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16

Research Site 38

North Miami, Florida, United States, 33162

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17

Research Site 159

Orlando, Florida, United States, 32825

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18

Research Site 41

Orlando, Florida, United States, 32825

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19

Research Site 16

Tamarac, Florida, United States, 33321

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20

Research Site 18

Tampa, Florida, United States, 33614

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21

Research Site 237

Lawrenceville, Georgia, United States, 30044

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22

Research Site 17

Park Ridge, Illinois, United States, 60068

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23

Research Site 167

Elkhart, Indiana, United States, 46514-2487

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24

Research Site 43

Elkhart, Indiana, United States, 46514

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25

Research Site 157

Indianapolis, Indiana, United States, 46290

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26

Research Site 28

Overland Park, Kansas, United States, 66211

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27

Research Site 23

Topeka, Kansas, United States, 66606

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28

Research Site 12

Annapolis, Maryland, United States, 21401

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29

Research Site 166

Baltimore, Maryland, United States, 21229

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30

Research Site 44

Baltimore, Maryland, United States, 21229

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31

Research Site 30

Flint, Michigan, United States, 48532

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32

Research Site 33

Jackson, Mississippi, United States, 39202

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33

Research Site 32

Olive Branch, Mississippi, United States, 38654

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34

Research Site 2

Jefferson City, Missouri, United States, 65109

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35

Research Site 232

St Louis, Missouri, United States, 63136

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36

Research Site 29

Fremont, Nebraska, United States, 68025

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37

Research Site 3

Omaha, Nebraska, United States, 68144

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38

Research Site 165

Summit, New Jersey, United States, 07901

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39

Research Site 77

Summit, New Jersey, United States, 07901

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40

Research Site 156

Long Island City, New York, United States, 11106

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41

Research Site 72

Long Island City, New York, United States, 11106

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42

Research Site 233

New York, New York, United States, 10016

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43

Research Site 228

New York, New York, United States, 10029

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44

Research Site 37

Asheboro, North Carolina, United States, 27203

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45

Research Site 36

Morehead City, North Carolina, United States, 28557

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46

Research Site 169

Wilmington, North Carolina, United States, 28401

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47

Research Site 22

Beavercreek, Ohio, United States, 45431

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48

Research Site 234

Columbus, Ohio, United States, 43214

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49

Research Site 164

Norman, Oklahoma, United States, 73072

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50

Research Site 76

Norman, Oklahoma, United States, 73072

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51

Research Site 31

Oklahoma City, Oklahoma, United States, 73112

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52

Research Site 26

Horsham, Pennsylvania, United States, 19044

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53

Research Site 8

Newport, Pennsylvania, United States, 17074

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54

Research Site 231

Philadelphia, Pennsylvania, United States, 19104

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55

Research Site 238

Fort Mill, South Carolina, United States, 29707

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56

Research Site 27

El Paso, Texas, United States, 19044

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57

Research Site 160

Fort Worth, Texas, United States, 76132

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58

Research Site 158

Houston, Texas, United States, 77061

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59

Research Site 73

Houston, Texas, United States, 77061

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60

Research Site 163

Houston, Texas, United States, 77090

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61

Research Site 75

Houston, Texas, United States, 77090

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62

Research Site 24

Houston, Texas, United States, 77095

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63

Research Site 230

Missouri City, Texas, United States, 77459

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64

Research Site 161

Plano, Texas, United States, 75093

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65

Research Site 74

Plano, Texas, United States, 75093

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66

Research Site 168

San Antonio, Texas, United States, 78230

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67

Research Site 13

Sugar Land, Texas, United States, 77479

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68

Research Site 170

Tomball, Texas, United States, 77375

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69

Research Site 25

Victoria, Texas, United States, 77901

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70

Research Site 15

Bountiful, Utah, United States, 84010

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71

Research Site 35

St. George, Utah, United States, 84790

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72

Research Site 10

Manassas, Virginia, United States, 20110

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73

Research Site 172

Ciudad Autonoma Buenos Aires, Argentina, 1425

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74

Research Site 173

Ciudad Autonoma Buenos Aires, Argentina, C1430CKE

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75

Research Site 171

Córdoba, Argentina, X5000AAW

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76

Research Site 239

Córdoba, Argentina, X5006CBI

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77

Research Site 240

Córdoba, Argentina, X5008HHW

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78

Research Site 86

Box Hill, Victoria, Australia, 3128

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79

Research Site 174

Nedlands, Western Australia, Australia, 6009

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80

Research Site 48

Gozée, Belgium, 6534

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81

Research Site 91

Gozée, Belgium, 6534

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82

Research Site 87

Hasselt, Belgium, 3500

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83

Research Site 47

Mechelen, Belgium, 2800

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84

Research Site 90

Mechelen, Belgium, 97770

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85

Research Site 46

Namur, Belgium, 5000

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86

Research Site 89

Namur, Belgium, 5380

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87

Research Site 175

Roeselare, Belgium, 8800

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88

Research Site 45

Wetteren, Belgium, 9230

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89

Research Site 88

Wetteren, Belgium, 9230

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90

Research Site 178

Belo Horizonte, Minas Gerais, Brazil, 30150-274

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91

Research Site 181

Aracaju, Sergipe, Brazil, 49055-530

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92

Research Site 180

Campinas, São Paulo, Brazil, 13060-080

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93

Research Site 176

Votuporanga, São Paulo, Brazil, 15500-269

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94

Research Site 177

São Paulo, Brazil, 04266-010

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95

Research Site 179

São Paulo, Brazil, 05403-900

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96

Research Site 187

Burgas, Bulgaria, 8000

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97

Research Site 100

Dimitrovgrad, Bulgaria, 6400

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98

Research Site 54

Kardzhali, Bulgaria, 6600

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99

Research Site 98

Kardzhali, Bulgaria, 6600

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100

Research Site 52

Kyustendil, Bulgaria, 2500

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101

Research Site 96

Kyustendil, Bulgaria, 2500

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102

Research Site 49

Pleven, Bulgaria, 5800

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103

Research Site 92

Pleven, Bulgaria, 5800

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104

Research Site 185

Plovdiv, Bulgaria, 4001

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105

Research Site 50

Plovdiv, Bulgaria, 4002

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106

Research Site 93

Plovdiv, Bulgaria, 4002

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107

Research Site 94

Rousse, Bulgaria, 7013

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108

Research Site 53

Sofia, Bulgaria, 1404

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109

Research Site 182

Sofia, Bulgaria, 1431

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110

Research Site 183

Sofia, Bulgaria, 1431

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111

Research Site 186

Sofia, Bulgaria, 1431

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112

Research Site 184

Sofia, Bulgaria, 1527

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113

Research Site 51

Sofia, Bulgaria, 1616

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114

Research Site 95

Sofia, Bulgaria, 1616

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115

Research Site 97

Sofia, Bulgaria, 1618

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116

Research Site 99

Stara Zagora, Bulgaria, 6010

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117

Research Site 20

Victoria, British Columbia, Canada, V8T5G4

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118

Research Site 103

Halifax, Nova Scotia, Canada, NS B3H 1V7

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119

Research Site 7

London, Ontario, Canada, N6A 5K8

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120

Research Site 101

Sarnia, Ontario, Canada, N7T 4X3

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121

Research Site 55

Sarnia, Ontario, Canada, N7T 4X3

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122

Research Site 241

Toronto, Ontario, Canada, M5G 2C4

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123

Research Site 102

Waterloo, Ontario, Canada, N2T 0C1

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124

Research Site 6

Chicoutimi, Quebec, Canada, G7H 7K9

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125

Research Site 5

Montreal, Quebec, Canada, H2W 1R7

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126

Research Site 4

Québec, Quebec, Canada, G1V 4W2

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127

Research Site 56

Kitchener, Canada, N2H5Z8

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128

Research Site 19

Québec, Canada, G1G5X1

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129

Research Site 191

Bengbu, Anhui, China, 233004

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130

Research Site 104

Beijing, Beijing Municipality, China, 100034

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131

Research Site 57

Beijing, Beijing Municipality, China, 100034

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132

Research Site 193

Beijing, Beijing Municipality, China, 100091

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133

Research Site 62

Guangzhou, Guangdong, China, 510000

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134

Research Site 112

Guangzhou, Guangdong, China, 510080

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135

Research Site 111

Guangzhou, Guangdong, China, 510180

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136

Research Site 114

Liuzhou, Guangxi Zhuang, China, 545006

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137

Research Site 63

Liuzhou, Guangxi Zhuang, China, 545006

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138

Research Site 106

Xingtai, Hebei, China, 054099

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139

Research Site 188

Luoyang, Henan, China, 471003

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140

Research Site 107

Changsha, Hu'nan, China, 410011

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141

Research Site 59

Changsha, Hu'nan, China, 410011

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142

Research Site 108

Changsha, Hu'nan, China, 410015

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143

Research Site 115

Baotou, Inner Mongolia, China, 014010

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144

Research Site 64

Baotou, Inner Mongolia, China, 14010

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145

Research Site 192

Suzhou, Jiangsu, China, 215002

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146

Research Site 110

Nanchang, Jiangxi, China, 330006

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147

Research Site 61

Nanchang, Jiangxi, China, 330006

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148

Research Site 190

Liaocheng, Shandong, China, 252000

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149

Research Site 243

Shanghai, Shanghai Municipality, China, 200040

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150

Research Site 189

Shanghai, Shanghai Municipality, China, 200050

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151

Research Site 105

Yuncheng, Shanxi, China, 44000

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152

Research Site 58

Yuncheng, Shanxi, China, 44000

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153

Research Site 113

Chengdu, Sichuan, China, 610072

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154

Research Site 242

Tianjin, Tianjin Municipality, China, 300121

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155

Research Site 109

Wenzhou, Zhejiang, China, 325000

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156

Research Site 60

Wenzhou, Zhejiang, China, 325000

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157

Research Site 194

Zagreb, Croatia, 10000

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158

Research Site 117

Hodonín, Czechia, 69501

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159

Research Site 65

Hodonín, Czechia, 69501

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160

Research Site 197

Hradec Králové, Czechia, 50005

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161

Research Site 118

Olomouc, Czechia, CZ77900

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162

Research Site 119

Prague, Czechia, 11000

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163

Research Site 66

Prague, Czechia, 11000

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164

Research Site 244

Prague, Czechia, 140 21

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165

Research Site 116

Praha 4-Krc, Czechia, 140 59

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166

Research Site 198

Teplice, Czechia, 41501

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167

Research Site 196

Trutnov, Czechia, 541 01

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168

Research Site 195

Ústí nad Labem, Czechia, 40113

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169

Research Site 199

Marseille, Bouches-du-Rhône, France, 13005

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170

Research Site 120

Pessac, Gironde, France, 33604

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171

Research Site 200

Paris, Paris, France, 75013

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172

Research Site 201

Magdeburg, Saxony-Anhalt, Germany, 39120

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173

Research Site 204

Budapest, Hungary, 1033

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174

Research Site 123

Budapest, Hungary, 1051

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175

Research Site 122

Budapest, Hungary, 1132

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176

Research Site 68

Budapest, Hungary, 1132

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177

Research Site 205

Miskolc, Hungary, 3530

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178

Research Site 121

Pécs, Hungary, 7623

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179

Research Site 67

Pécs, Hungary, 7623

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180

Research Site 202

Veszprém, Hungary, 8200

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181

Research Site 203

Zalaegerszeg, Hungary, 8900

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182

Research Site 209

Rozzano, Milano, Italy, 20089

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183

Research Site 245

Bologna, Italy, 40138

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184

Research Site 208

Brescia, Italy, 25123

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185

Research Site 207

Milan, Italy, 20162

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186

Research Site 210

Palermo, Italy, 90127

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187

Research Site 206

Roma, Italy, 00168

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188

Research Site 212

Daugavpils, Latvia, LV-5410

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189

Research Site 124

Daugavpils, Latvia, LV-5417

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190

Research Site 211

Riga, Latvia, LV-1002

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191

Research Site 125

Riga, Latvia, LV1063

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192

Research Site 69

Riga, Latvia, LV1063

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193

Research Site 126

Kaunas, Lithuania, 49387

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194

Research Site 70

Kaunas, Lithuania, 49387

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195

Research Site 246

Kaunas, Lithuania, 49449

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196

Research Site 213

Kaunas, Lithuania, LT-50177

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197

Research Site 127

Šiauliai, Lithuania, LT-76206

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198

Research Site 214

Vilnius, Lithuania, LT-08661

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199

Research Site 128

Christchurch, New Zealand, 08011

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200

Research Site 129

Wellington, New Zealand, 6021

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201

Research Site 130

Elblag, Poland, 82-300

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202

Research Site 78

Elblag, Poland, 82-300

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203

Research Site 247

Gdynia, Poland, 81-338

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204

Research Site 134

Katowice, Poland, 40-156

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205

Research Site 81

Katowice, Poland, 40-156

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206

Research Site 141

Katowice, Poland, 40-752

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207

Research Site 85

Katowice, Poland, 40-752

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208

Research Site 138

Krakow, Poland, 31-501

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209

Research Site 83

Krakow, Poland, 31-501

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210

Research Site 136

Lodz, Poland, 91-363

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211

Research Site 131

Lodz, Poland, 94-255

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212

Research Site 79

Lodz, Poland, 94-255

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213

Research Site 132

Malbork, Poland, 82-200

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214

Research Site 80

Malbork, Poland, 82-200

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215

Research Site 135

Szczecin, Poland, 71- 500

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216

Research Site 139

Warsaw, Poland, 00-215

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217

Research Site 84

Warsaw, Poland, 00-215

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218

Research Site 216

Warsaw, Poland, 03-291

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219

Research Site 133

Wroclaw, Poland, 51-314

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220

Research Site 140

Wroclaw, Poland, 53-673

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221

Research Site 215

Zamość, Poland, 22-400

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222

Research Site 137

Żarów, Poland, 58-130

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223

Research Site 82

Żarów, Poland, 58-130

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224

Research Site 142

Bucharest, Romania, 010192

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225

Research Site 217

Galati, Romania, 800291

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226

Research Site 143

Ploieşti, Romania, 100342

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227

Research Site 144

Târgu Mureş, Romania, 540136

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228

Research Site 145

Timișoara, Romania, 300362

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229

Research Site 147

Bardejov, Slovakia, 08501

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230

Research Site 146

Košice, Slovakia, 04001

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231

Research Site 218

Moldava nad Bodvou, Slovakia, 045 01

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232

Research Site 248

Nitra, Slovakia, 950 01

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233

Research Site 148

Rožňava, Slovakia, 048 01

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234

Research Site 219

Krugersdorp, Gauteng, South Africa, 1739

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Research Site 222

Cape Town, Western Cape, South Africa, 7500

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236

Research Site 220

Cape Town, Western Cape, South Africa, 7570

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237

Research Site 221

Cape Town, Western Cape, South Africa, 7925

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238

Research Site 149

Somerset West, Western Cape, South Africa, 7130

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239

Research Site 224

A Coruña, La Coruña, Spain, 15006

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240

Research Site 223

Barcelona, Spain, 08035

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241

Research Site 226

Madrid, Spain, 28041

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242

Research Site 150

Seville, Spain, 41013

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243

Research Site 225

Valencia, Spain, 46010

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244

Research Site 151

Zaragoza, Spain, 50009

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245

Research Site 152

Plymouth, Devon, United Kingdom, PL5 3JB

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246

Research Site 71

Plymouth, Devon, United Kingdom, PL5 3JB

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247

Research Site 153

Torquay, Devon, United Kingdom, TQ2 7AA

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248

Research Site 227

London, Greater London, United Kingdom, EC1M 6BQ

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Research Team

M

Medical Monitor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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