Clinical trial NCT02219490: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Keywords: Hepatitis C Genotype 1
Compensated Cirrhosis
Cirrhosis
Naive
Hepatitis C
Hepatitis C Virus
Treatment-Experienced
Relapser
Null responder
Non responder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 1596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Detailed description: This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Eligibility criteria: Inclusion Criteria:

1. Males and females at least 18 years old at screening
2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
3. Chronic hepatitis C, genotype 1 infection
4. Males must be surgically sterile or agree to practice acceptable forms of birth control
5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
4. Confirmed presence of hepatocellular carcinoma
5. History of solid organ transplant

Primary outcomes:
measure: All-Cause Death: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver-Related Death: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver Decompensation: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver Transplantation: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Hepatocellular Carcinoma: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Secondary outcomes:
measure: Change From Baseline in FibroScan Score by SVR12 Status
timeFrame: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: CHU Bab El Oued /ID# 145420
city: Algiers
country: Algeria
facility: CHU Bologhine Hospital /ID# 145421
city: Algiers
country: Algeria
facility: CHU Mustapha Bacha /ID# 132130
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney /ID# 131001
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital /ID# 130999
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 130997
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital /ID# 131003
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 131004
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 131002
state: South Australia
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 131000
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 130998
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 131017
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 131018
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 131015
state: Wien
city: Brussels
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 131019
state: Bruxelles-Capitale
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 131021
state: Vlaams-Brabant
city: Sofia
country: Bulgaria
facility: Tokuda Hospital Sofia /ID# 131022
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 131026
city: Sofia
country: Bulgaria
facility: Univ Hosp for Active Treat /ID# 131023
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center /ID# 131027
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina /ID# 131025
city: Calgary
country: Canada
facility: University of Calgary /ID# 134370
state: Alberta
city: Edmonton
country: Canada
facility: GI Research & Associates /ID# 132169
state: Alberta
city: Vancouver
country: Canada
facility: LAIR Centre /ID# 130970
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre /ID# 134369
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute /ID# 132171
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital /ID# 131210
state: New Brunswick
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 132170
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital /ID# 132134
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre /ID# 132168
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Asso /ID# 130968
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuel /ID# 132167
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 132165
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 132166
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 132132
state: Quebec
city: Hvidovre
country: Denmark
facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031
state: Hovedstaden
city: Odense C
country: Denmark
facility: Odense University Hospital /ID# 131029
state: Syddanmark
city: Aarhus
country: Denmark
facility: Aarhus Univ Hospital, Skejby /ID# 131030
city: Helsinki
country: Finland
facility: Helsinki University Hospital /ID# 131034
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital /ID# 131032
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 132177
state: Bouches-du-Rhone
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 131038
state: Franche-Comte
city: Pessac CEDEX
country: France
facility: Hopital Haut-Lévêque /ID# 131036
state: Gironde
city: Montpellier CEDEX 5
country: France
facility: Hopital Saint Eloi /ID# 131037
state: Herault
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 132179
state: Pays-de-la-Loire
city: Bondy
country: France
facility: Hopital Jean Verdier /ID# 135877
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 131041
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 131042
city: Nice
country: France
facility: Duplicate_Hopital lArchet 2 /ID# 131040
city: Rennes
country: France
facility: CHRU Pontchaillou /ID# 132173
city: Strasbourg cedex
country: France
facility: CHU Strasbourg - Hopital Civil /ID# 132174
city: Toulouse
country: France
facility: Hopital Universitaire Purpan Hopital Rangueil /ID# 131035
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg /ID# 131044
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 134371
state: Baden-Wuerttemberg
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045
state: Baden-Wuerttemberg
city: Munich
country: Germany
facility: LMU Klinikum der Universitat Muchen /ID# 131049
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 131055
state: Hessen
city: Düsseldorf
country: Germany
facility: Zentru fur HIV und Heaptogastroenterologie /ID# 131052
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 131048
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 131054
city: Muenster
country: Germany
facility: Centrum für interdisziplinaere Medizin /ID# 131046
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 131057
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 131088
state: Attiki
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 131056
city: Beaumont
country: Ireland
facility: Beaumont Hospital /ID# 131089
state: Dublin
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 132180
state: Dublin
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital /ID# 132181
state: Dublin
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 131092
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 132182
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 131090
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 131091
city: Bologna
country: Italy
facility: Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095
state: Emilia-Romagna
city: Cona
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102
state: Ferrara
city: San Giovanni Rotondo
country: Italy
facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190
state: Foggia
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 131098
state: Lazio
city: Milan
country: Italy
facility: Ospedale San Raffaele IRCCS /ID# 131093
state: Lombardia
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata /ID# 132185
state: Roma
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 132197
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195
city: Messina
country: Italy
facility: A.O.U. Policlinico G. Martino /ID# 132193
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097
city: Milan
country: Italy
facility: Ospedale S Giuseppe /ID# 132194
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 131096
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 132191
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma /ID# 132183
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192
city: Turin
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196
city: Tijuana
country: Mexico
facility: Hospital General de Tijuana /ID# 130972
state: Baja California
city: Guadalajara
country: Mexico
facility: Cife /Id# 130974
state: Jalisco
city: Ciudad de Mexico
country: Mexico
facility: ITESM campus Ciudad de Mexico /ID# 132383
city: Delegacion Tlalpan
country: Mexico
facility: Instituto Metropolitano de Inv /ID# 132201
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975
city: Mexico City
country: Mexico
facility: CIF-BIOTEC/Medica Sur /ID# 134971
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 132206
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum /ID# 132205
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum /ID# 132204
city: Lorenskog
country: Norway
facility: Akershus Universitetssykehus_MAIN /ID# 132212
state: Akershus
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF /ID# 132213
state: Sor-Trondelag
city: Stavanger
country: Norway
facility: Stavanger University Hospital /ID# 132211
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107
state: Lodzkie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115
state: Lubelskie
city: Warsaw
country: Poland
facility: Wojewodzki Szpital Zakazny /ID# 131112
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108
state: Podlaskie
city: Myslowice
country: Poland
facility: ID Clinic /ID# 131111
state: Slaskie
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117
city: Sector 2
country: Romania
facility: Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni /ID# 131121
state: Bucuresti
city: Timisoara
country: Romania
facility: Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126
state: Timis
city: Bucuresti
country: Romania
facility: Institutul Nat. de Boli Infectioase /ID# 131124
city: Iasi
country: Romania
facility: SC Gastromedica SRL /ID# 131127
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog /ID# 132277
state: Samarskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270
state: Tatarstan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: South-Ural State Med. Academy /ID# 132274
city: Kemerovo
country: Russian Federation
facility: Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center n.a. Loginov /ID# 132266
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Russian Academy of Science /ID# 132289
city: Moscow
country: Russian Federation
facility: I. M. Sechenov First Moscow State Medical University /ID# 132275
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #24 /ID# 132268
city: Moscow
country: Russian Federation
facility: Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288
city: Novosibirsk
country: Russian Federation
facility: Clinical Infectious Diseases Hospital #1 /ID# 132272
city: Samara
country: Russian Federation
facility: Samara State Medical University /ID# 136913
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University /ID# 132279
city: Tolyatti
country: Russian Federation
facility: Tolyatti City Clinical Hospital #1 /ID# 132273
city: Tyumen
country: Russian Federation
facility: Multidisciplinary Consultative and Diagnostic Center /ID# 131130
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1 /ID# 132267
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City /ID# 145129
city: Riyadh
country: Saudi Arabia
facility: Ministry Nat Guard Hosp Health /ID# 145126
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospita /ID# 132291
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias /ID# 131138
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 132293
state: Barcelona
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 131141
state: Cantabria
city: Donostia
country: Spain
facility: Hospital Donostia /ID# 131144
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases /ID# 131140
state: Illes Balears
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucia /ID# 131139
state: Murcia
city: Barakaldo
country: Spain
facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143
state: Vizcaya
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna - CHUAC /ID# 131137
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 131135
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 131131
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 131133
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 131132
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 131136
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 131134
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 132292
city: Malmo
country: Sweden
facility: Skane University hospital /ID# 131146
state: Skane Lan
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 131145
state: Stockholms Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital /ID# 131147
state: Vastra Gotalands Lan
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 131148
state: Sankt Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich /ID# 134881
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern /ID# 132294
city: Konak
country: Turkey
facility: Izmir Tepecik Training and Research Hospital /ID# 134968
state: Izmir
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 131150
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 131151
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty /ID# 132297
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty /ID# 131153
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 132298
city: Trabzon
country: Turkey
facility: Karadeniz University /ID# 131152
city: Poole
country: United Kingdom
facility: Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306
state: Dorset
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 131161
state: Hampshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 132302
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust /ID# 131159
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 131162
state: Scotland
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 131154
city: Dundee
country: United Kingdom
facility: Duplicate_NHS Tayside /ID# 132300
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 134368
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 132305
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trusts /ID# 131157
city: Plymouth
country: United Kingdom
facility: University Hospital Plymouth NHS Trust /ID# 131160
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 131158
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 131156
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 132301
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: