A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD)
Last Updated   April 24, 2024 - 21:02
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
SUMMARY
Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).
CONDITIONS
- Fistulizing Crohns Disease
- Perianal Crohns Disease
ELIGIBILITY
Inclusion Criteria:
* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
* Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
* Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)
Exclusion Criteria:
* Has a very severe luminal disease activity
* History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
* Any medical contraindications preventing study participation
* Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
DETAILS
Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).
LOCATIONS
Country (22) | City or Province (133) | Status |
United States | Birmingham, AL University of Alabama at Birmingham |
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United States | Germantown, TN Gastro One |
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United States | Kansas City, KS Kansas University Medical Center |
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United States | Lexington, KY University of Kentucky Chandler Medical Center |
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United States | Louisville, KY University of Louisville |
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United States | Miami, FL University of Miami |
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United States | Naples, FL Gastroenterology Group Of Naples |
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United States | Nashville, TN Vanderbilt University Medical Center |
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United States | New Haven, CT Yale University |
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United States | New York, NY Mount Sinai School of Medicine |
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United States | Oklahoma City, OK Digestive Disease Specialists Inc |
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United States | Orlando, FL AdventHealth Medical Group Blood & Marrow Transplant at Orlando |
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United States | Saint Louis, MO Washington University School of Medicine |
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United States | Seattle, WA Swedish Medical Center |
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United States | Tyler, TX Tyler Research Institute, LLC |
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United Kingdom | Hull Hull University Teaching Hospitals NHS Trust |
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United Kingdom | London Guy's and St Thomas' NHS Foundation Trust |
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United Kingdom | London London North West University Healthcare NHS Trust |
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United Kingdom | London St George's University Hospital NHS Foundation Trust |
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United Kingdom | Newcastle Upon Tyne Newcastle upon Tyne Hospitals NHS Foundation Trust |
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United Kingdom | Salford Pennine Acute Hospitals NHS Trust |
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Turkey | Ankara Gazi University Medical Faculty |
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Turkey | Istanbul Acibadem Kozyatagi Hospital |
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Turkey | Istanbul Istanbul University Cerrahpasa Medical Faculty |
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Turkey | Mersin Mersin University Medical Faculty Hospital |
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Turkey | İzmir Ege University Medical Faculty |
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Taiwan | Changhua Changhua Christian Hospital |
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Taiwan | Taichung Taichung Veterans General Hospital |
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Taiwan | Taipei City National Taiwan University Hospital |
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Taiwan | Taoyuan City Chang Gung Memorial Hospital Linkou Branch |
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Spain | Barcelona, BA Hosp. Clinic de Barcelona |
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Spain | Ferrol Hosp. Arquitecto Marcide |
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Spain | Madrid, MD Hosp. Univ. de La Princesa |
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Spain | Majadahonda, MD Hosp. Univ. Pta. de Hierro Majadahonda |
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Spain | Sevilla Hosp. Virgen Macarena |
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Spain | Vigo, PO Hosp. Alvaro Cunqueiro |
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Spain | Zaragoza, ZR Hosp. Univ. Miguel Servet |
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South Korea | Busan Inje University Haeundae Paik Hospital |
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South Korea | Daegu Yeungnam University Hospital |
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South Korea | Gyeonggi-do, 41 Seoul National University Bundang Hospital |
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South Korea | Seoul Gangnam Severance Hospital, Yonsei University Health System |
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South Korea | Seoul Seoul National University Hospital |
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Saudi Arabia | Dammam King Fahad Specialist hospital |
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Saudi Arabia | Jeddah King Abdulaziz Medical City |
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Saudi Arabia | Riyadh King Faisal Specialist Hospital & Research Center |
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Saudi Arabia | Riyadh King Saud University Medical City |
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Portugal | Braga, Braga Ccab - Hosp. de Braga |
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Portugal | Lisboa Chlc - Hosp. Sto Antonio Dos Capuchos |
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Portugal | Porto H. Santo António - Centro Hospitalar do Porto |
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Poland | Bialystok Gastromed Kralisz Romatowski Stachurska Sp. j. |
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Poland | Krakow Centrum Medyczne Promed |
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Poland | Lodz Centrum Medyczne Med-Gastr |
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Poland | Rzeszow Centrum Medyczne Medyk |
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Poland | Szczecin Twoja Przychodnia - Szczecinskie Centrum Medyczne |
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Poland | Torun GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii |
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Poland | Warszawa WIP Warsaw IBD Point Profesor Kierkus |
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Poland | Wroclaw Melita Medical Sp. z o.o. |
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Poland | Wrocław Centrum Medyczne Oporow |
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Netherlands | Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam |
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Netherlands | Nijmegen, GE Radboudumc |
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Netherlands | Utrecht, UT UMC Utrecht |
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Jordan | Amman Abdali Hospital |
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Jordan | Amman Jordan University Hospital |
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Jordan | Amman The Speciality Hospital (TSH) / Advanced Clinical Center |
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Jordan | Irbid Irbid Specialty Hospital |
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Jordan | Irbid King Abdullah University Hospital |
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Japan | Abiko KOKIKAI Tokatsu Tsujinaka Hospital |
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Japan | Chikushino-shi Fukuoka University Chikushi Hospital |
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Japan | Fukuoka Fukuoka University Hospital |
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Japan | Fukuoka-ken Kitakyushu Municipal Medical Center |
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Japan | Hiroshima shi Hiroshima University Hospital |
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Japan | Hukuoka Hospital of the University of Occupational and Environmental Health |
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Japan | Kagoshima Sameshima Hospital |
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Japan | Kashihara, 29 Nara Medical University Hospital |
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Japan | Kashiwa Tsujinaka Hospital Kashiwanoha |
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Japan | Nagasaki, 42 Nagasaki University Hospital |
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Japan | Nagoya Kojunkai Daido Clinic |
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Japan | Nagoya Nagoya University Hospital |
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Japan | Nishinomiya, 28 The Hospital of Hyogo College of Medicine |
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Japan | Okayama, 33 Okayama University Hospital |
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Japan | Osaka, 27 Kinshukai Infusion Clinic |
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Japan | Sakai, 27 JOHAS Osaka Rosai Hospital |
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Japan | Sapporo, 01 Sapporo Higashi Tokushukai Hospital |
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Japan | Shinjuku-ku, 13 Tokyo Yamate Medical Center |
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Japan | Shizuoka Matsuda Hospital |
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Japan | Suita, 27 Osaka University Hospital |
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Japan | Tokyo, 13 Kyorin University Hospital |
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Japan | Toyota Ieda Hospital |
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Japan | Tsu Mie University Hospital |
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Japan | Yokkaichi, 24 Yokkaichi Hazu Medical Center |
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Japan | Yokohama, 14 Yokohama Municipal Citizens Hospital |
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Italy | Milano Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico |
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Italy | Negrar ( Ve) Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar |
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Italy | Pisa Azienda Ospedaliera Universitaria Pisana |
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Italy | RHO Azienda Ospedaliera G.Salvini Ospedale di Rho |
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Italy | San Giovanni Rotondo Casa Sollievo della Sofferenza |
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Israel | Haifa, H Rambam Medical Center |
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Israel | Jerusalem Shaare Zedek Medical Center |
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Israel | Petah Tikva Rabin Medical Center Beilinson Campus |
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Hungary | Budapest Magyar Honvedseg Egeszsegugyi Kozpont |
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Hungary | Budapest Semmelweis Egyetem |
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Hungary | Budapest Semmelweis Egyetem |
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Hungary | Pecs Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika |
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Greece | Athens Evangelismos General Hospital of Athens |
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Greece | Athens Hippokration Hospital |
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Greece | Heraklion University Hospital of Heraklion |
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Greece | Patras Patras University Hospital |
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Germany | Berlin, BE Charite - Campus Mitte |
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Germany | Frankfurt, HE JWG-University Hospital |
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Germany | Kiel, SH Universitatsklinikum Schleswig Holstein Kiel |
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Germany | Mannheim, BW Universitaetsklinikum Mannheim |
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France | Neuilly-sur-Seine Clinique Ambroise Pare |
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France | Nice CHU de Nice Hopital de l Archet |
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France | Pierre-Benite Centre Hospitalier Lyon Sud |
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France | Rennes CHRU Hopital de Pontchaillou |
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France | Vandoeuvre-les-Nancy CHRU Nancy-Brabois |
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Czechia | Ceske Budejovice Nemocnice Ceske Budejovice, a.s. |
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Czechia | Praha 9 ISCARE a.s. |
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Canada | London, ON London Health Sciences Centre |
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Canada | Montreal, QC McGill University Health Centre |
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Canada | Toronto, ON Mount Sinai Hospital |
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Belgium | Bruxelles, BRU Hopital Erasme |
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Belgium | Leuven UZ Leuven |
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Belgium | Liege CHU Sart Tilman |
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Australia | Adelaide, SA Flinders Medical Centre |
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Australia | Fitzroy, VIC St Vincent's Hospital - Melbourne |
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Australia | Liverpool, NSW Liverpool Hospital |
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Australia | Murdoch, WA Fiona Stanley Hospital |
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Australia | Newtown, NSW Royal Prince Alfred Hospital |
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Australia | North Terrace, SA Royal Adelaide Hospital |
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Australia | Parkville, VIC Royal Melbourne Hospital |
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Australia | Perth, WA Royal Perth Hospital |
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Australia | South Brisbane, QLD Mater Hospital |
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