Actively Recruiting

Age: 18Years - 130Years
All Genders
NCT06252753

Observational Study Protocol: LIVER-R

Led by AstraZeneca · Updated on 2025-12-26

4490

Participants Needed

138

Research Sites

406 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

I

ICON plc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).

CONDITIONS

Official Title

Observational Study Protocol: LIVER-R

Who Can Participate

Age: 18Years - 130Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and legally an adult in the country at the start of durvalumab treatment
  • Confirmed diagnosis of primary hepatobiliary cancer (unresectable hepatocellular carcinoma or advanced biliary tract cancer) by the treating physician
  • Hepatobiliary cancer type approved for durvalumab-based treatment in the country or treated as part of an early access program
  • Informed consent obtained according to country regulations on or after the start of durvalumab treatment
Not Eligible

You will not qualify if you...

  • Currently participating, or planning to participate, in any clinical trial for investigational treatment for hepatobiliary cancers from diagnosis until starting durvalumab treatment
  • Received other systemic therapies for hepatobiliary cancer from diagnosis until starting durvalumab treatment
  • Received a liver transplant during the baseline period before starting durvalumab treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 138 locations

1

Research Site

Birmingham, Alabama, United States, 35233-1932

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2

Research Site

Mobile, Alabama, United States, 36604

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3

Research Site

Phoenix, Arizona, United States, 85004

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4

Research Site

Coronado, California, United States, 92118

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5

Research Site

Los Angeles, California, United States, 90048

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6

Research Site

Walnut Creek, California, United States, 94598

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7

Research Site

Clermont, Florida, United States, 34711

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8

Research Site

Gainesville, Florida, United States, 32610

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9

Research Site

Tampa, Florida, United States, 33606

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10

Research Site

Augusta, Georgia, United States, 30912

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11

Research Site

Evergreen Park, Illinois, United States, 60805

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12

Research Site

Hinsdale, Illinois, United States, 60521

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13

Research Site

Baton Rouge, Louisiana, United States, 70808

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14

Research Site

Osage Beach, Missouri, United States, 65065

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15

Research Site

White Plains, New York, United States, 10601

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16

Research Site

Canton, Ohio, United States, 44718

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17

Research Site

Bethlehem, Pennsylvania, United States, 18015

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18

Research Site

Philadelphia, Pennsylvania, United States, 19141

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19

Research Site

Dallas, Texas, United States, 75390-8567

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20

Research Site

Temple, Texas, United States, 76508

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21

Research Site

Spokane, Washington, United States, 99204

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22

Research Site

Garran, Australian Capital Territory, Australia, 2605

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23

Research Site

Heidelberg, Victoria, Australia, 3084

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24

Research Site

Melbourne, Victoria, Australia, 3004

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25

Research Site

Murdoch, Western Australia, Australia, 6150

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26

Research Site

Sankt Pölten, Lower Austria, Austria, 3100

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27

Research Site

Vienna, State of Vienna, Austria, 1090

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28

Research Site

Linz, Upper Austria, Austria, 4010

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29

Research Site

Brussels, Anderlecht, Belgium, 1070

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30

Research Site

Bonheiden, Antwerp, Belgium, 2820

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31

Research Site

Edegem, Antwerp, Belgium, 2650

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32

Research Site

Leuven, Brabant, Belgium, 3000

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33

Research Site

Liège, Wallonia, Belgium, 4000

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34

Research Site

Stene, West Flanders, Belgium, 8400

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35

Research Site

Curitiba, Paraná, Brazil, 81480-580

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36

Research Site

Recife - PE, Recife - PE, Brazil, 50070-490

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37

Research Site

Porto Alegre, Rio Grande do Sul, Brazil, 90035-001

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38

Research Site

Morumbi, São Paulo, Brazil, 05651-901

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39

Research Site

São Paulo, Brazil, 01246-000

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40

Research Site

São Paulo, Brazil, 04538-132

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41

Research Site

Halifax, Nova Scotia, Canada, B3H 2Y9

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42

Research Site

Strasbourg, Alsace, France, 67000

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43

Research Site

Grenoble, Auvergne-Rhône-Alpes, France, 38700

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44

Research Site

St-Malo, Brittany Region, France, 35403

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45

Research Site

Mulhouse, Grand Est, France, 68100

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46

Research Site

Boulogne-sur-Mer, Hauts-de-France, France, 62200

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47

Research Site

Poitiers, New Aquitaine, France, 86000

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48

Research Site

Avignon, Provence-Alpes-Côte d'Azur Region, France, 84918

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49

Research Site

Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008

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50

Research Site

Paris, Île-de-France Region, France, 75012

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51

Research Site

Paris, Île-de-France Region, France, 75014

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52

Research Site

Heidenheim, Baden W Rttemberg, Germany, 89522

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53

Research Site

Konstanz, Baden-Wurttemberg, Germany, 78484

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54

Research Site

Mannheim, Baden-Wurttemberg, Germany, 68167

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55

Research Site

Schorndorf, Baden-Wurttemberg, Germany, 73614

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56

Research Site

Stuttgart, Baden-Wurttemberg, Germany, 70174

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57

Research Site

Augsburg, Bavaria, Germany, 86150

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58

Research Site

Munich, Bavaria, Germany, 81377

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59

Research Site

Bremenhaven, Free Hanseatic City of Bremen, Germany, 27574

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60

Research Site

Kassel, Hesse, Germany, 34125

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61

Research Site

Marburg, Hesse, Germany, 35033

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62

Research Site

Wiesbaden, Hesse Land, Germany, 65189

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63

Research Site

Göttingen, Lower Saxony, Germany, 37075

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64

Research Site

Hanover, Lower Saxony, Germany, 30161

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65

Research Site

Hanover, Lower Saxony, Germany, 30459

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66

Research Site

Aachen, North Rhine-Westphalia, Germany, 52074

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67

Research Site

Bochum, North Rhine-Westphalia, Germany, 44892

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68

Research Site

Dortmund, North Rhine-Westphalia, Germany, 44137

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69

Research Site

Moers, North Rhine-Westphalia, Germany, 47441

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70

Research Site

Stolberg, North Rhine-Westphalia, Germany, 52222

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71

Research Site

Koblenz, Rhineland-Palatinate, Germany, 56073

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72

Research Site

Dresden, Saxony, Germany, 1307

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73

Research Site

Leipzig, Saxony, Germany, 4103

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74

Research Site

Halle, Saxony-Anhalt, Germany, 06108

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75

Research Site

Magdeburg, Saxony-Anhalt, Germany, 39120

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76

Research Site

Neumünster, Schleswig-Holstein, Germany, 24534

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77

Research Site

Berlin, Germany, 13353

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78

Research Site

Hamburg, Germany, 20259

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79

Research Site

Hamburg, Germany, 22291

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80

Research Site

Chaïdári, Athens, Greece, 12462

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81

Research Site

Athens, Attica, Greece, 11527

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82

Research Site

Athens, Attica, Greece, 14564

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83

Research Site

Thessaloniki, Central Macedonia, Greece, 54639

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84

Research Site

Thessaloniki, Central Macedonia, Greece, 55236

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85

Research Site

Larissa, Thessaly, Greece, 41110

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86

Research Site

Nahariya, Northern Didstrict, Israel, 22100

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87

Research Site

Ramat Gan, Tel Aviv, Israel, 52621

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88

Research Site

Jerusalem, Israel, 9103102

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89

Research Site

Tel Aviv, Israel, 6423906

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90

Research Site

Naples, Campania, Italy, 80131

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91

Research Site

Rome, Lazio, Italy, 00128

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92

Research Site

Rome, Lazio, Italy, 00168

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93

Research Site

Brescia, Lombardy, Italy, 25123

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94

Research Site

Milan, Lombardy, Italy, 20132

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95

Research Site

Milan, Lombardy, Italy, 20133

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96

Research Site

Rozzano, Lombardy, Italy, 20089

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97

Research Site

Turin, Piedmont, Italy, 10126

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98

Research Site

Monserrato, Sardinia, Italy, 09042

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99

Research Site

Pisa, Tuscany, Italy, 56124

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100

Research Site

Nagoya, Aichi-ken, Japan, 466-8550

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101

Research Site

Kashiwa-shi, Chiba, Japan, 277-8577

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102

Research Site

Kurume, Fukuoka, Japan, 830-0011

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103

Research Site

Kanazawa, Ishikawa-ken, Japan, 920-8641

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104

Research Site

Yokohama, Kanagawa, Japan, 241-8515

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105

Research Site

Kyoto, Kyoto, Japan, 606-8507

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106

Research Site

Sendai, Miyagi, Japan, 980-8574

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107

Research Site

Ōsaka-sayama, Osaka, Japan, 589-8511

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108

Research Site

Lisbon, Portugal, 1400 - 038

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109

Research Site

Lisbon, Portugal, 1649-028

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110

Research Site

San Juan, Rio Piedras, Puerto Rico, 00935

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111

Research Site

Bucharest, Romania, 22328

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112

Research Site

Cluj-Napoca, Romania, 400162

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113

Research Site

Iași, Romania, 700483

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114

Research Site

Riyadh, Ar Riyadh, Saudi Arabia, 12231

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115

Research Site

Jeddah, Mecca Region, Saudi Arabia, 22384

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116

Research Site

Singapore, Singapore, 329563

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117

Research Site

Santiago de Compostela, A Coruna, Spain, 15706

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118

Research Site

Zaragoza, Aragon, Spain, 50009

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119

Research Site

Santander, Cantabria, Spain, 39008

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120

Research Site

Burgos, Castille and León, Spain, 9006

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121

Research Site

Poniente Sur, Cordoba, Spain, 14004

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122

Research Site

Ourense, Galicia, Spain, 32005

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123

Research Site

El Palmar, Murcia, Spain, 30120

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124

Research Site

Barcelona, Spain, 8035

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125

Research Site

Madrid, Spain, 28007

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126

Research Site

Madrid, Spain, 28034

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127

Research Site

Madrid, Spain, 28040

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128

Research Site

Oviedo, Spain, 33011

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129

Research Site

Pamplona, Spain, 31008

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130

Research Site

Santa Cruz de Tenerife, Spain, 38010

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131

Research Site

Seville, Spain, 41009

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132

Research Site

Valencia, Spain, 46010

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133

Research Site

Zurich, Switzerland, 8032

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134

Research Site

Kaohsiung City, Taiwan, 82445

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135

Research Site

Taipei, Taiwan, 100225

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136

Research Site

Taipei, Taiwan, 11217

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137

Research Site

Taoyuan City, Taiwan, 33305

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138

Research Site

Mohammed Bin Zayed City, Abu Dhabi Emirate, United Arab Emirates, 92510

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Observational Study Protocol: LIVER-R | DecenTrialz