SELECTIONLTE: Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Sponsor
Galapagos NV (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02914535
Collaborator
Gilead Sciences (Industry)
1,173
323
5
116.2
3.6
0
Study Details
Study Description
Brief Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1173 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Only 3 arms are blinded in this study.
Primary Purpose:
Treatment
Official Title:
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Actual Study Start Date
:
Feb 23, 2017
Anticipated Primary Completion Date
:
Oct 1, 2026
Anticipated Study Completion Date
:
Nov 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Filgotinib 200 mg (blinded dosing) Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo
Tablet(s) administered orally once daily
|
| Experimental: Filgotinib 100 mg (blinded dosing) Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo
Tablet(s) administered orally once daily
|
| Placebo Comparator: Placebo (blinded dosing) Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
Drug: Placebo
Tablet(s) administered orally once daily
|
| Experimental: Filgotinib 200 mg (open-label) Filgotinib 200 mg for up to 336 weeks |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
|
| Experimental: Filgotinib 100 mg (open-label) Filgotinib 100 mg for up to 336 weeks |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [Up to 336 weeks plus 30 days]
Secondary Outcome Measures
- Change From Baseline in Components of Mayo Clinic Score (MCS) [Baseline and up to 336 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
-
Must have enrolled in Gilead-sponsored UC parent protocol GS-US-418-3898
-
Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
-
Females of childbearing potential must have a negative pregnancy test at Day 1
-
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol for the duration described
-
Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Key Exclusion Criteria:
-
Known hypersensitivity to the study drug
-
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
-
Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the participants
-
Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Digestive Health Specialists Of The Southeast | Dothan | Alabama | United States | 36305 |
| 2 | Mayo Clinic Arizona | Scottsdale | Arizona | United States | 85259 |
| 3 | VA Long Beach Healthcare System | Long Beach | California | United States | 90822 |
| 4 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 5 | South Denver Gastroenterology, PC | Lone Tree | Colorado | United States | 80124 |
| 6 | Connecticut GI PC-Research Division | Farmington | Connecticut | United States | 06032 |
| 7 | UF Clinical Research Center | Gainesville | Florida | United States | 32610 |
| 8 | Florida Research Institute | Lakewood Ranch | Florida | United States | 34211 |
| 9 | University of Miami Crohn's and Colitis Center | Miami | Florida | United States | 33136 |
| 10 | Cordova Research Institute | Miami | Florida | United States | 33155 |
| 11 | Gastroenterology Group of Naples | Naples | Florida | United States | 34102 |
| 12 | Advanced Medical Research Center | Port Orange | Florida | United States | 32127 |
| 13 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 14 | Florida Medical Clinic, P.A | Zephyrhills | Florida | United States | 33540 |
| 15 | Gastroenterology Associates Of Central Georgia, LLC | Macon | Georgia | United States | 31201 |
| 16 | Gastrointestinal Specialists of Georgia | Marietta | Georgia | United States | 30060 |
| 17 | Atlanta Gastroenterology Specialist, PC | Suwanee | Georgia | United States | 30024 |
| 18 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 19 | University of Louisville, Clinical Trials Unit | Louisville | Kentucky | United States | 40202 |
| 20 | Delta Research Partners, LLC | Monroe | Louisiana | United States | 71201 |
| 21 | Louisiana Research Center, LLC | Shreveport | Louisiana | United States | 71105 |
| 22 | Investigative Clinical Research | Annapolis | Maryland | United States | 21401 |
| 23 | MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
| 24 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
| 25 | Meritus Center for Clinical Research | Hagerstown | Maryland | United States | 21742 |
| 26 | Massachusetts General Hospital - Crohn's and Colitis Center | Boston | Massachusetts | United States | 02114 |
| 27 | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | United States | 48047 |
| 28 | Center for Digestive Health Research | Troy | Michigan | United States | 48098 |
| 29 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 30 | Kansas City Research Institute | Kansas City | Missouri | United States | 64131 |
| 31 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 32 | NY Scientific | Brooklyn | New York | United States | 11235 |
| 33 | NYU Langone Long Island Clinical Research Associates | Great Neck | New York | United States | 11021 |
| 34 | Carolina's GI Research LLC | Raleigh | North Carolina | United States | 27607 |
| 35 | Fargo Gastroenterology and Hepatology Clinic | Fargo | North Dakota | United States | 58103 |
| 36 | Consultants for Clinical Research | Cincinnati | Ohio | United States | 45219 |
| 37 | UC Health Physicians Clifton | Cincinnati | Ohio | United States | 45219 |
| 38 | Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | United States | 44060 |
| 39 | Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina | United States | 29118 |
| 40 | Rapid City Medical Center | Rapid City | South Dakota | United States | 57701 |
| 41 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 42 | Quality Medical Research | Nashville | Tennessee | United States | 37211 |
| 43 | Vanderbilt University Medical Center - IBD Clinic | Nashville | Tennessee | United States | 37212-1375 |
| 44 | San Antonio Military Medical Center | Fort Sam Houston | Texas | United States | 78219 |
| 45 | DHAT Research Institute | Garland | Texas | United States | 75044 |
| 46 | Baylor College of Medicine - Baylor Medical Center | Houston | Texas | United States | 77030 |
| 47 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
| 48 | Clinical Associates in Research Therapeutics of America, LLC | San Antonio | Texas | United States | 78212 |
| 49 | Gastroenterology Research of San Antonio | San Antonio | Texas | United States | 78229 |
| 50 | TDDC San Marcos | San Marcos | Texas | United States | 78666 |
| 51 | Texas Digestive Disease Consultants | Southlake | Texas | United States | 76092 |
| 52 | Spring Gastroenterology | The Woodlands | Texas | United States | 77380 |
| 53 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
| 54 | Gastroenterology Associates of Tidewater | Chesapeake | Virginia | United States | 23320 |
| 55 | McGuire DVAMC | Richmond | Virginia | United States | 23249 |
| 56 | University of Wisconsin Hospital & Clinics | Madison | Wisconsin | United States | 53705 |
| 57 | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | United States | 53225 |
| 58 | Instituto de Investigaciones Clinicas Mar del Plata | Mar del Plata | Argentina | B7600FZN | |
| 59 | Instituto Médico Cer | Quilmes | Argentina | B1878 | |
| 60 | Monash Medical Centre | Clayton | New South Wales | Australia | 3168 |
| 61 | St. Vincent's Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
| 62 | Nepean Hospital | Kingswood | New South Wales | Australia | 2747 |
| 63 | Coastal Digestive Health | Mountain Creek | Queensland | Australia | 4557 |
| 64 | Mater Misericordiae Ltd | South Brisbane | Queensland | Australia | 4101 |
| 65 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 66 | The Queen Elizabeth Hospital | Woodville South | South Australia | Australia | 5011 |
| 67 | Footscray Hospital | Footscray | Victoria | Australia | 3011 |
| 68 | Cabrini Hospital | Malvern | Victoria | Australia | 3144 |
| 69 | Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 70 | Universitatsklinik Innsbruck | Innsbruck | Austria | 6020 | |
| 71 | AKH-Medizinische Universitat Wien | Wien | Austria | 1090 | |
| 72 | GZA Ziekenhuizen, campus Sint-Vincentius | Antwerpen | Belgium | 2018 | |
| 73 | CUB Hopital Erasme | Brussel | Belgium | 1070 | |
| 74 | Universitair Ziekenhuis Leuven | Leuven | Belgium | 3000 | |
| 75 | Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph | Liège | Belgium | 4000 | |
| 76 | MHAT Sveti Pantaleymon- Pleven OOD | Pleven | Bulgaria | 5800 | |
| 77 | "MDHAT Dr. St.Cherkezov" AD | Veliko Tarnovo | Bulgaria | 5000 | |
| 78 | MHAT "Sveta Petka" AD | Vidin | Bulgaria | 3700 | |
| 79 | University of Calgary, Heritage Medical Research Clinic | Calgary | Alberta | Canada | T2N 4Z6 |
| 80 | The Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 81 | Hamilton Health Sciences Corporation, McMaster University Medical Centre | Hamilton | Ontario | Canada | L8S 4K1 |
| 82 | Toronto Digestive Disease Associates Inc. | Vaughan | Ontario | Canada | L4L 4Y7 |
| 83 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 84 | Clinical Hospital Dubrava | Zagreb | Croatia | 10000 | |
| 85 | University Hospital Center Zagreb | Zagreb | Croatia | 10000 | |
| 86 | Hepato-Gastroenterology HK, s.r.o. | Hradec Kralove | Czechia | 500 12 | |
| 87 | Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni | Mlada Boleslav | Czechia | 293 01 | |
| 88 | G.E.P. Clinic, s r.o. | Praha 3 | Czechia | 130 00 | |
| 89 | ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety | Praha 9 | Czechia | 190 00 | |
| 90 | CHU Amiens Picardie | Amiens Cedex 1 | France | 80054 | |
| 91 | CHU de Caen | Caen Cedex 9 | France | 14033 | |
| 92 | CHU de Clermont-Ferrand - Hopital d'Estaing | Clermont-Ferrand | France | 63003 | |
| 93 | APHP - Hopital Beaujon - Clichy - Universite Paris VII | Clichy | France | 92110 | |
| 94 | CHU de Dijon Bourgogne - Hopital Francois Mitterand | Dijon | France | 21079 | |
| 95 | CHU Grenoble Alpes | La Tronche | France | 38700 | |
| 96 | Hopital Universitaire de Bicetre | Le Kremlin Bicetre | France | 94270 | |
| 97 | Centre Hospitalier Regional Universitaire de Lille | Lille | France | 59000 | |
| 98 | Hopital Nord | Marseille | France | 13915 | |
| 99 | CHU de Montpellier-Hopital Saint Eloi | Montpellier | France | 34295 | |
| 100 | CHU Hotel-Dieu | Nantes | France | 44093 | |
| 101 | Hopital de l'Archet 2 | Nice | France | 06202 | |
| 102 | CHU de Bordeaux - Hopital Haut Leveque | Pessac | France | 33600 | |
| 103 | Centre Hospitalier Universitaire de Lyon Sud | Pierre-Benite | France | 69495 | |
| 104 | Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes Cedex 9 | France | 35033 | |
| 105 | CHU de Saint Etienne - Hopital Nord | Saint Priest en Jarez | France | 42055 | |
| 106 | CHU de Toulouse - Hopital Rangueil | Toulouse | France | 31059 | |
| 107 | CHU de Nancy - Hopital Brabois Adultes | Vandoeuvre Les Nancy | France | 54511 | |
| 108 | Unimed Ajara LLC - Batumi Referral Hospital | Batumi | Georgia | 6010 | |
| 109 | Medi Club Georgia LLC | Tbilisi | Georgia | 0160 | |
| 110 | Universitatsklinikum Schleswig-Holstein | Kiel | Schleswig Holstein | Germany | 24105 |
| 111 | Charite Universitaetsmedizin Berlin | Berlin | Germany | 10117 | |
| 112 | Charite - Universitatsmedizin Berlin | Berlin | Germany | 13353 | |
| 113 | DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin | Berlin | Germany | 14050 | |
| 114 | Stadtisches Klinikum Braunschweig gGmbH | Braunschweig | Germany | 38126 | |
| 115 | Agaplesion Markus Krankenhaus | Frankfurt am Main | Germany | 60431 | |
| 116 | Universitatsklinikum Freiburg | Freiburg | Germany | 79106 | |
| 117 | Asklepios Westklinikum Hamburg | Hamburg | Germany | 22559 | |
| 118 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 119 | Gastroenterologische Gemeinschaftspraxis Herne | Herne | Germany | 44623 | |
| 120 | Universitatsklinikum Jena | Jena | Germany | 07747 | |
| 121 | Universitaetsklinik Koln | Koln | Germany | 50937 | |
| 122 | EUGASTRO GmbH | Leipzig | Germany | 04103 | |
| 123 | Klinikum Luneburg | Lüneburg | Germany | 21339 | |
| 124 | Gastroenterologische Gemeinschaftspraxis Minden | Minden | Germany | 32423 | |
| 125 | Klinikum der Universitat Munchen - Grosshadern | Muenchen | Germany | 81377 | |
| 126 | Universitaetsklinikum Tuebingen | Tuebingen | Germany | 72074 | |
| 127 | Universitatsklinikum Ulm, Zentrum Fur Innere Medizin | Ulm | Germany | 89081 | |
| 128 | General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit | Athens | Greece | 11527 | |
| 129 | Princess Margaret Hospital | Hong Kong | Hong Kong | ||
| 130 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 131 | Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital | Shatin | Hong Kong | ||
| 132 | Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia | Bekescsaba | Hungary | 5600 | |
| 133 | Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo | Budapest | Hungary | 1097 | |
| 134 | Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly | Budapest | Hungary | 1125 | |
| 135 | Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia | Debrecen | Hungary | 4032 | |
| 136 | Bugat Pal Korhaz, Belgyogyaszat | Gyöngyös | Hungary | 3200 | |
| 137 | Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia | Mosonmagyarovar | Hungary | 9200 | |
| 138 | Kaizen Hospital | Ahmedabad | India | 380052 | |
| 139 | M S Ramaiah Medical College and Hospital | Bangalore | India | 560054 | |
| 140 | Apollo Speciality Hospital | Chennai | India | 600035 | |
| 141 | VGM Hospital Institute of Gastroenterology | Coimbatore | India | 641005 | |
| 142 | Gleneagles Global Hospitals | Hyderabad | India | 500004 | |
| 143 | Citizens Specialty Hospital | Hyderabad | India | 500019 | |
| 144 | Centre for Liver Research & Diagnostics | Hyderabad | India | 500058 | |
| 145 | SR Kalla Memorial Gastro and General Hospital | Jaipur | India | 302001 | |
| 146 | S.M.S Medical College & Hospitals | Jaipur | India | 302004 | |
| 147 | Dayanand Medical College & Hospital | Ludhiana | India | 141001 | |
| 148 | Kasturba Medical College (KMC) Hospital | Mangaluru | India | 575001 | |
| 149 | Lokmanya Tilak Municipal General Hospital | Mumbai | India | 400022 | |
| 150 | Midas Multispeciality Hospital Pvt. Ltd | Nagpur | India | 440010 | |
| 151 | Suretech Hospital & Research Centre Ltd | Nagpur | India | 440012 | |
| 152 | Grant Medical Foundation Ruby Hall Clinic | Pune | India | 411001 | |
| 153 | Shree Giriraj Multispeciality Hospital | Rajkot | India | 360002 | |
| 154 | Gandhi Hospital | Secunderabad | India | 500003 | |
| 155 | Surat Institute of Digestive Sciences | Surat | India | 395002 | |
| 156 | Kasturba Hospital Medical College | Udupi | India | 576104 | |
| 157 | Sterling Hospital | Vadodara | India | 390007 | |
| 158 | Samvedna Hospital | Varanasi | India | 221005 | |
| 159 | Beaumont Hospital | Dublin | Ireland | 9 | |
| 160 | Bnai Zion Medical Center | Haifa | Israel | 31048 | |
| 161 | Rambam Medical Health Care Campus | Haifa | Israel | 3109601 | |
| 162 | Shaare Zedek Medical Center | Jerusalem | Israel | 9103102 | |
| 163 | Hadassah Medical Center | Jerusalem | Israel | 9112001 | |
| 164 | Rabin Medical Center | Petah Tikva | Israel | 4941492 | |
| 165 | UOC Gastroenterologia II | Castellana Grotte | Italy | 70013 | |
| 166 | U.O. Fisiopatologia Digestiva | Catanzaro | Italy | 88100 | |
| 167 | Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina | Chieti | Italy | 66100 | |
| 168 | Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico | Milano | Italy | 20121 | |
| 169 | UOC Gastroenterologia | Padova | Italy | 35128 | |
| 170 | Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello | Pisa | Italy | 56124 | |
| 171 | UOC Gastroenterologia ed Endoscopia Digestiva | Roma | Italy | 128 | |
| 172 | Istituto Clinico Humanitas | Rozzano | Italy | 20089 | |
| 173 | Nagasaki University Hospital | Nagasaki-shi | Nagasaki | Japan | 8528501 |
| 174 | Osaka University Hospital | Suita | Osaka | Japan | 565-0871 |
| 175 | Medical Hospital, Tokyo Medical and Dental University | Bunkyo-ku | Japan | 113-8519 | |
| 176 | Fukuoka University Chikushi Hospital | Chikushino-shi | Japan | 818-8502 | |
| 177 | Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital | Chuo-ku | Japan | 060-0033 | |
| 178 | Japanese Red Cross Fukuoka Hospital | Fukuoka-shi | Japan | 815-8555 | |
| 179 | Tokai University Hachioji Hospital | Hachioji | Japan | 192-0032 | |
| 180 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 | |
| 181 | Fukuoka University Hospital | Jonan-ku | Japan | 814-0180 | |
| 182 | Ofuna Chuo Hospital | Kamakura | Japan | 247-0056 | |
| 183 | Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center | Kitakyushu-shi | Japan | 802-0077 | |
| 184 | Yamanashi Prefectural Central Hospital | Kofu-shi | Japan | 400-8506 | |
| 185 | Kurume University Hospital | Kurume-shi | Japan | 830-0011 | |
| 186 | Hidaka Coloproctology Clinic | Kurume-shi | Japan | 839-0809 | |
| 187 | University Hospital, Kyoto Prefectural University of Medicine | Kyoto-shi | Japan | 602-8566 | |
| 188 | The Jikei University Hospital | Minato-Ku | Japan | 105-8471 | |
| 189 | Kitasato University Kitasato Institute Hospital | Minato-ku | Japan | 108-8642 | |
| 190 | Kyorin University Hospital | Mitaka-shi | Japan | 181-8611 | |
| 191 | Iwate Medical University Hospital | Morioka-shi | Japan | 020-8505 | |
| 192 | Aichi Medical University Hospital | Nagakute-shi | Japan | 480-1195 | |
| 193 | Saiseikai Niigata Daini Hospital | Nishi-ku | Japan | 950-1104 | |
| 194 | Hyogo College of Medicine College Hospital | Nishinomiya | Japan | 663-8501 | |
| 195 | Ishida IBD Clinic | Oita-shi | Japan | 870-0823 | |
| 196 | Okayama University Hospital | Okayama-city | Japan | 700-8558 | |
| 197 | Kinshukai Infusion Clinic | Osaka | Japan | 530-0011 | |
| 198 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
| 199 | Wakakusa-Daiichi Hospital | Osaka | Japan | 579-8056 | |
| 200 | Shiga University of Medical Science Hospital | Otsu | Japan | 520-2192 | |
| 201 | Saga-Ken Medical Centre Koseikan | Saga-shi | Japan | 840-8571 | |
| 202 | Kitasato University Hospital,THE KITASATO INSTITUTE | Sagamihara | Japan | 252-0375 | |
| 203 | Saga University Hospital | Saga | Japan | 849-8501 | |
| 204 | Tokito Clinic | Saitama | Japan | 336-0963 | |
| 205 | Toho University Sakura Medical Center | Sakura | Japan | 285-8741 | |
| 206 | Sapporo Higashi Tokushukai Hospital | Sapporo-shi | Japan | 065-0033 | |
| 207 | National Hospital Organization Sendai Medical Center | Sendai | Japan | 983-8520 | |
| 208 | Tokyo Yamate Medical Center | Shinjuku-ku | Japan | 169-0073 | |
| 209 | Kagawa Prefectural Central Hospital | Takamatsu-shi | Japan | 760-8557 | |
| 210 | National Hospital Organization Takasaki General Medical Center | Takasaki-shi | Japan | 3700829 | |
| 211 | Osaka Medical College Hospital | Takatsuki | Japan | 569-8686 | |
| 212 | Ieda Hospital | Toyota-shi | Japan | 470-1219 | |
| 213 | Wakayama Medical University Hospital | Wakayama-shi | Japan | 641-8509 | |
| 214 | Colo-proctology Center Matsushima Clinic | Yokohama-shi | Japan | 220-0045 | |
| 215 | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do | Korea, Republic of | 16247 |
| 216 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 217 | Yeungnam University Hospital | Daegu | Korea, Republic of | 42415 | |
| 218 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 219 | Yonsei University Health System, Severance Hospital | Seoul | Korea, Republic of | 03722 | |
| 220 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 221 | Division of Gastroenterology, Department of Medicine, Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 222 | Kyung Hee University Hospital | Seoul | Korea, Republic of | 130-872 | |
| 223 | Yonsei University Wonju Severance Christian Hospital | Wonju | Korea, Republic of | 220-701 | |
| 224 | Hospital Pulau Pinang | George Town | Malaysia | 10990 | |
| 225 | Hospital Queen Elizabeth | Kota Kinabalu | Malaysia | 88586 | |
| 226 | PCR-Phylasis Clinicas Research S. de R.L. de C.V. | Cuautitlán Izcalli | Mexico | 54750 | |
| 227 | Academic Medical Center (AMC) | Amsterdam | Netherlands | 1100 | |
| 228 | Gelre Hospital | Apeldoorn | Netherlands | 7334 | |
| 229 | University Medical Center Utrecht | Utrecht | Netherlands | 3584 CX | |
| 230 | Christchurch Hospital | Christchurch | New Zealand | 8011 | |
| 231 | Auckland City Hospital | Grafton | New Zealand | 1023 | |
| 232 | Wellington Hospital | Newtown | New Zealand | 6021 | |
| 233 | Bay of Plenty District Health Board - Tauranga Hospital | Tauranga | New Zealand | 3112 | |
| 234 | Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych | Bialystok | Poland | 15-276 | |
| 235 | VITAMED Galaj i Cichomski spólka jawna | Bydgoszcz | Poland | 85-079 | |
| 236 | Gabinet Lekarski Janusz Rudzinski | Bydgoszcz | Poland | 85-681 | |
| 237 | NZOZ INTER-MED, Centrum Endoskopowe | Czestochowa | Poland | 42-217 | |
| 238 | Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS | Katowice | Poland | 40-659 | |
| 239 | Gabinet Endoskopii Przewodu Pokarmowego | Krakow | Poland | 31-009 | |
| 240 | Krakowskie Centrum Medyczne Sp. z o.o | Kraków | Poland | 31-501 | |
| 241 | Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. | Ksawerów | Poland | 95-054 | |
| 242 | Santa Familia, Centrum Badan, Profilaktyki i Leczenia | Lodz | Poland | 90-302 | |
| 243 | Centrum Innowacyjnych Terapii Sp. z o.o. | Piaseczno | Poland | 05-500 | |
| 244 | Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k. | Poznan | Poland | 60-848 | |
| 245 | Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski | Rzeszów | Poland | 35-301 | |
| 246 | Endoskopia Sp. z o.o. | Sopot | Poland | 81-756 | |
| 247 | Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 248 | GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii | Torun | Poland | 87-100 | |
| 249 | H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. | Tychy | Poland | 43-100 | |
| 250 | Centrum Zdrowia MDM | Warszawa | Poland | 00-635 | |
| 251 | Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie | Warszawa | Poland | 02-507 | |
| 252 | Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz | Warszawa | Poland | 03-580 | |
| 253 | Bodyclinic | Warszawa | Poland | 03-712 | |
| 254 | Centrum Medyczne Oporow | Wroclaw | Poland | 52-416 | |
| 255 | Hospital da Senhora da Oliveira Guimaraes, E.P.E. | Guimaraes | Portugal | 4835-044 | |
| 256 | Centro Hospitalar de Sao Joao, EPE | Porto | Portugal | 4200-319 | |
| 257 | MedLife, Gastroenterologie | Bucuresti | Romania | 010719 | |
| 258 | Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie | Bucuresti | Romania | 020125 | |
| 259 | Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie | Oradea | Romania | 410066 | |
| 260 | Cabinet Particular Policlinic Algomed SRL | Timisoara | Romania | 300002 | |
| 261 | State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital" | Chelyabinsk | Russian Federation | 454076 | |
| 262 | State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital | Irkutsk | Russian Federation | 669079 | |
| 263 | Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety | Moscow | Russian Federation | 115446 | |
| 264 | State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" | Moscow | Russian Federation | 127015 | |
| 265 | State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy" | Moscow | Russian Federation | 129110 | |
| 266 | State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A. | Nizhniy Novgorod | Russian Federation | 603126 | |
| 267 | State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12" | Novosibirsk | Russian Federation | 630084 | |
| 268 | State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital" | Novosibirsk | Russian Federation | 630087 | |
| 269 | "Riat" LLC | Saint Petersburg | Russian Federation | 193163 | |
| 270 | Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38" | Saint-Petersburg | Russian Federation | 191015 | |
| 271 | "Scientific Research Centre ECO-safety" LLC | Saint-Petersburg | Russian Federation | 196143 | |
| 272 | State Healthcare Institution "Regional Clinical Hospital" | Saratov | Russian Federation | 410053 | |
| 273 | Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC | Smolensk | Russian Federation | 214019 | |
| 274 | Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>> | Tyumen | Russian Federation | 625026 | |
| 275 | Zvezdara University Medical Center | Belgrade | Serbia | 3810-972 | |
| 276 | Singapore General Hospital | Singapore | Singapore | 169608 | |
| 277 | KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra | Nitra | Slovakia | 950 01 | |
| 278 | Dr MJ Prins | Cape Town | South Africa | 7500 | |
| 279 | Peermed Clinical Trial Centre | Johannesburg | South Africa | 1619 | |
| 280 | Centro Medico Teknon | Barcelona | Spain | 08022 | |
| 281 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 282 | Hospital Universitario de Fuenlabrada | Madrid | Spain | 28942 | |
| 283 | Hospital Universitario Central de Asturias | Oviedo | Spain | 33006 | |
| 284 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 | |
| 285 | Skane University Hospital | Malmo | Sweden | SE-205-02 | |
| 286 | Danderyd University Hospital Corp | Stockholm | Sweden | 182 88 | |
| 287 | Akademiska Sjukhuset | Uppsala | Sweden | 75185 | |
| 288 | Gastroenterologische Praxis Balsiger, Seibold und Partner | Bern | Switzerland | 3012 | |
| 289 | Universitätsspital Zürich | Zurich | Switzerland | 8091 | |
| 290 | Changhua Christian Hospital | Changhua | Taiwan | 500 | |
| 291 | National Taiwan University Hospital | Taipei | Taiwan | 100 | |
| 292 | Mackay Memorial Hospital, Taipei | Taipei | Taiwan | 10449 | |
| 293 | Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch | Taoyuan | Taiwan | 33305 | |
| 294 | Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department | Cherkasy | Ukraine | 18000 | |
| 295 | Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical | Chernivtsi | Ukraine | 58000 | |
| 296 | Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department | Chernivtsi | Ukraine | 58000 | |
| 297 | State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" | Dnipropetrovsk | Ukraine | 49000 | |
| 298 | Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National | Ivano-Frankivsk | Ukraine | 76018 | |
| 299 | Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department | Kharkiv | Ukraine | 61037 | |
| 300 | L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine" | Kharkiv | Ukraine | 61039 | |
| 301 | Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1 | Kharkiv | Ukraine | 63101 | |
| 302 | Kyiv City Clinical Hospital No. 18, Proctology Department | Kyiv | Ukraine | 01030 | |
| 303 | Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department | Kyiv | Ukraine | 1103 | |
| 304 | Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway" | Odessa | Ukraine | 65010 | |
| 305 | Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department | Odessa | Ukraine | 65025 | |
| 306 | Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology | Ternopil | Ukraine | 46002 | |
| 307 | Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1 | Vinnytsia | Ukraine | 21005 | |
| 308 | M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department | Vinnytsia | Ukraine | 21018 | |
| 309 | Medical Center LLC "Health Clinic" | Vinnytsia | Ukraine | 21029 | |
| 310 | Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council | Zaporizhzhya | Ukraine | 69600 | |
| 311 | Norfolk and Norwich University Hospital NHS Foundation Trust | Norwich | Norfolk | United Kingdom | NR4 7UY |
| 312 | The Pennine Acute Hospitals NHS Trust | Bury | United Kingdom | BL9 7TD | |
| 313 | Cambridge University Hospital NHS Foundation Trust | Cambridge | United Kingdom | CB2 0QQ | |
| 314 | Royal Derby Hospital | Derby | United Kingdom | DE22 3NE | |
| 315 | NHS Lothian | Edinburgh | United Kingdom | EH4 2XU | |
| 316 | Glasgow Clinical Research Facility - Queen Elizabeth University Hospital | Glasgow | United Kingdom | G51 4TF | |
| 317 | NHS Greater Glasgow and Clyde | Glasgow | United Kingdom | G52 3NQ | |
| 318 | Wycombe Hospital | High Wycombe | United Kingdom | HP11 2TT | |
| 319 | Imperial College Healthcare NHS Trust, St Mary's Hospital | London | United Kingdom | W2 1NY | |
| 320 | Biomedical Research Unit | Nottingham | United Kingdom | NG7 2UH | |
| 321 | Oxford University Hospitals NHS Trust | Oxford | United Kingdom | OX3 9DU | |
| 322 | St Helens and Knowsley Teaching Hospitals NHS Trust | Prescot | United Kingdom | L35 5DR | |
| 323 | Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Galapagos NV
- Gilead Sciences
Investigators
- Study Director: Galapagos Study Director, Galapagos NV
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT02914535
Other Study ID Numbers:
- GS-US-418-3899
- 2016-002765-58
First Posted:
Sep 26, 2016
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: