Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02914600




Registration number
NCT02914600
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016

Titles & IDs
Public title
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Scientific title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2016-002763-34
Secondary ID [2] 0 0
GS-US-419-3896
Universal Trial Number (UTN)
Trial acronym
DIVERSITY LTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo

Experimental: Filgotinib 200 mg - Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg.

Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Experimental: Filgotinib 100 mg - Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg.

Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Placebo comparator: Placebo - Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation.

Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).


Treatment: Drugs: Filgotinib
Tablet administered orally once a day

Treatment: Drugs: Placebo
Tablet administered orally once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From the First Dose to Week 312
Secondary outcome [1] 0 0
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
Timepoint [1] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Secondary outcome [2] 0 0
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
Timepoint [2] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Secondary outcome [3] 0 0
Change From Baseline in CDAI Scores
Timepoint [3] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

Eligibility
Key inclusion criteria
Key

* 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 a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
* Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
* Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 individual unsuitable for the study or would prevent compliance with the study protocol
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
* Use of prohibited concomitant medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2023
Sample size
Target
Accrual to date
Final
1188
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [6] 0 0
Coral Sea Clinical Research Institute (Mackay) - North Mackay
Recruitment hospital [7] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [10] 0 0
Emeritus Research - Camberwell
Recruitment hospital [11] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [12] 0 0
Footscray Hospital - Footscray
Recruitment hospital [13] 0 0
Austin Health - Heidelberg
Recruitment hospital [14] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [15] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4557 - Mountain Creek
Recruitment postcode(s) [6] 0 0
4740 - North Mackay
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5011 - Woodville South
Recruitment postcode(s) [10] 0 0
3124 - Camberwell
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
3011 - Footscray
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3144 - Malvern
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
North Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Rosario
Country [36] 0 0
Austria
State/province [36] 0 0
Innsbruck
Country [37] 0 0
Austria
State/province [37] 0 0
Klagenfurt am Wörthersee
Country [38] 0 0
Austria
State/province [38] 0 0
Wien
Country [39] 0 0
Belgium
State/province [39] 0 0
Antwerpen
Country [40] 0 0
Belgium
State/province [40] 0 0
Bonheiden
Country [41] 0 0
Belgium
State/province [41] 0 0
Brussel
Country [42] 0 0
Belgium
State/province [42] 0 0
Edegem
Country [43] 0 0
Belgium
State/province [43] 0 0
Gent
Country [44] 0 0
Belgium
State/province [44] 0 0
Leuven
Country [45] 0 0
Belgium
State/province [45] 0 0
Liege
Country [46] 0 0
Belgium
State/province [46] 0 0
Liège
Country [47] 0 0
Belgium
State/province [47] 0 0
Roeselare
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Samokov
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Sliven
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Veliko Tarnovo
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Vidin
Country [52] 0 0
Canada
State/province [52] 0 0
Barrie
Country [53] 0 0
Canada
State/province [53] 0 0
Calgary
Country [54] 0 0
Canada
State/province [54] 0 0
Hamilton
Country [55] 0 0
Canada
State/province [55] 0 0
London
Country [56] 0 0
Canada
State/province [56] 0 0
North York
Country [57] 0 0
Canada
State/province [57] 0 0
Oakville
Country [58] 0 0
Canada
State/province [58] 0 0
Saskatoon
Country [59] 0 0
Canada
State/province [59] 0 0
Toronto
Country [60] 0 0
Canada
State/province [60] 0 0
Vancouver
Country [61] 0 0
Canada
State/province [61] 0 0
Vaughan
Country [62] 0 0
Canada
State/province [62] 0 0
Victoria
Country [63] 0 0
Croatia
State/province [63] 0 0
Osijek
Country [64] 0 0
Croatia
State/province [64] 0 0
Zagreb
Country [65] 0 0
Czechia
State/province [65] 0 0
Hradec Kralove
Country [66] 0 0
Czechia
State/province [66] 0 0
Mlada Boleslav
Country [67] 0 0
Czechia
State/province [67] 0 0
Praha 3
Country [68] 0 0
Czechia
State/province [68] 0 0
Praha 4
Country [69] 0 0
Czechia
State/province [69] 0 0
Praha 9
Country [70] 0 0
France
State/province [70] 0 0
Amiens Cedex 1
Country [71] 0 0
France
State/province [71] 0 0
Caen Cedex 9
Country [72] 0 0
France
State/province [72] 0 0
Clermont-Ferrand
Country [73] 0 0
France
State/province [73] 0 0
Clichy
Country [74] 0 0
France
State/province [74] 0 0
Créteil Cedex
Country [75] 0 0
France
State/province [75] 0 0
Dijon
Country [76] 0 0
France
State/province [76] 0 0
La Tronche
Country [77] 0 0
France
State/province [77] 0 0
Le Kremlin Bicetre
Country [78] 0 0
France
State/province [78] 0 0
Lille
Country [79] 0 0
France
State/province [79] 0 0
Marseille
Country [80] 0 0
France
State/province [80] 0 0
Montpellier
Country [81] 0 0
France
State/province [81] 0 0
Nantes
Country [82] 0 0
France
State/province [82] 0 0
Nice
Country [83] 0 0
France
State/province [83] 0 0
Pessac
Country [84] 0 0
France
State/province [84] 0 0
Pierre-Benite
Country [85] 0 0
France
State/province [85] 0 0
Pringy Cedex
Country [86] 0 0
France
State/province [86] 0 0
Rennes Cedex 9
Country [87] 0 0
France
State/province [87] 0 0
Saint Priest en Jarez
Country [88] 0 0
France
State/province [88] 0 0
Strasbourg
Country [89] 0 0
France
State/province [89] 0 0
Toulouse Cedex 9
Country [90] 0 0
France
State/province [90] 0 0
Toulouse
Country [91] 0 0
France
State/province [91] 0 0
Vandoeuvre-les-Nancy Cedex
Country [92] 0 0
Georgia
State/province [92] 0 0
Batumi
Country [93] 0 0
Georgia
State/province [93] 0 0
Tbilisi
Country [94] 0 0
Georgia
State/province [94] 0 0
Telavi
Country [95] 0 0
Germany
State/province [95] 0 0
Berlin
Country [96] 0 0
Germany
State/province [96] 0 0
Braunschweig
Country [97] 0 0
Germany
State/province [97] 0 0
Dresden
Country [98] 0 0
Germany
State/province [98] 0 0
Frankfurt am Main
Country [99] 0 0
Germany
State/province [99] 0 0
Freiburg
Country [100] 0 0
Germany
State/province [100] 0 0
Hamburg
Country [101] 0 0
Germany
State/province [101] 0 0
Hannover
Country [102] 0 0
Germany
State/province [102] 0 0
Heidelberg
Country [103] 0 0
Germany
State/province [103] 0 0
Herne
Country [104] 0 0
Germany
State/province [104] 0 0
Jena
Country [105] 0 0
Germany
State/province [105] 0 0
Kiel
Country [106] 0 0
Germany
State/province [106] 0 0
Koln
Country [107] 0 0
Germany
State/province [107] 0 0
Leipzig
Country [108] 0 0
Germany
State/province [108] 0 0
Lüneburg
Country [109] 0 0
Germany
State/province [109] 0 0
Minden
Country [110] 0 0
Germany
State/province [110] 0 0
Muenchen
Country [111] 0 0
Germany
State/province [111] 0 0
Rostock
Country [112] 0 0
Germany
State/province [112] 0 0
Tuebingen
Country [113] 0 0
Germany
State/province [113] 0 0
Ulm
Country [114] 0 0
Greece
State/province [114] 0 0
Athens
Country [115] 0 0
Greece
State/province [115] 0 0
Ioannina
Country [116] 0 0
Greece
State/province [116] 0 0
Patra
Country [117] 0 0
Greece
State/province [117] 0 0
Thessaloniki
Country [118] 0 0
Hong Kong
State/province [118] 0 0
Hong Kong
Country [119] 0 0
Hong Kong
State/province [119] 0 0
Shatin
Country [120] 0 0
Hong Kong
State/province [120] 0 0
Tuen Mun
Country [121] 0 0
Hungary
State/province [121] 0 0
Bekescsaba
Country [122] 0 0
Hungary
State/province [122] 0 0
Budapest
Country [123] 0 0
Hungary
State/province [123] 0 0
Debrecen
Country [124] 0 0
Hungary
State/province [124] 0 0
Gyöngyös
Country [125] 0 0
Hungary
State/province [125] 0 0
Mosonmagyarovar
Country [126] 0 0
Iceland
State/province [126] 0 0
Reykjavik
Country [127] 0 0
India
State/province [127] 0 0
Kerala
Country [128] 0 0
India
State/province [128] 0 0
Ahmedabad
Country [129] 0 0
India
State/province [129] 0 0
Bangalore
Country [130] 0 0
India
State/province [130] 0 0
Chennai
Country [131] 0 0
India
State/province [131] 0 0
Coimbatore
Country [132] 0 0
India
State/province [132] 0 0
Ernakulam
Country [133] 0 0
India
State/province [133] 0 0
Gurgaon
Country [134] 0 0
India
State/province [134] 0 0
Hyderabad
Country [135] 0 0
India
State/province [135] 0 0
Jaipur
Country [136] 0 0
India
State/province [136] 0 0
Kolkata
Country [137] 0 0
India
State/province [137] 0 0
Lucknow
Country [138] 0 0
India
State/province [138] 0 0
Ludhiana
Country [139] 0 0
India
State/province [139] 0 0
Mangaluru
Country [140] 0 0
India
State/province [140] 0 0
Mumbai
Country [141] 0 0
India
State/province [141] 0 0
Nagpur
Country [142] 0 0
India
State/province [142] 0 0
New Delhi
Country [143] 0 0
India
State/province [143] 0 0
Pune
Country [144] 0 0
India
State/province [144] 0 0
Rajkot
Country [145] 0 0
India
State/province [145] 0 0
Secunderabad
Country [146] 0 0
India
State/province [146] 0 0
Surat
Country [147] 0 0
India
State/province [147] 0 0
Udupi
Country [148] 0 0
India
State/province [148] 0 0
Vadodara
Country [149] 0 0
India
State/province [149] 0 0
Varanasi
Country [150] 0 0
Ireland
State/province [150] 0 0
Dublin
Country [151] 0 0
Ireland
State/province [151] 0 0
Galway
Country [152] 0 0
Israel
State/province [152] 0 0
Afula
Country [153] 0 0
Israel
State/province [153] 0 0
Beer-Sheva
Country [154] 0 0
Israel
State/province [154] 0 0
Haifa
Country [155] 0 0
Israel
State/province [155] 0 0
Holon
Country [156] 0 0
Israel
State/province [156] 0 0
Jerusalem
Country [157] 0 0
Israel
State/province [157] 0 0
Kefar Sava
Country [158] 0 0
Israel
State/province [158] 0 0
Petah Tikva
Country [159] 0 0
Israel
State/province [159] 0 0
Ramat Gan
Country [160] 0 0
Israel
State/province [160] 0 0
Tel Aviv-Yafo
Country [161] 0 0
Italy
State/province [161] 0 0
Castellana Grotte
Country [162] 0 0
Italy
State/province [162] 0 0
Catanzaro
Country [163] 0 0
Italy
State/province [163] 0 0
Cento
Country [164] 0 0
Italy
State/province [164] 0 0
Chieti
Country [165] 0 0
Italy
State/province [165] 0 0
Firenze
Country [166] 0 0
Italy
State/province [166] 0 0
Milano
Country [167] 0 0
Italy
State/province [167] 0 0
Modena
Country [168] 0 0
Italy
State/province [168] 0 0
Padova
Country [169] 0 0
Italy
State/province [169] 0 0
Pisa
Country [170] 0 0
Italy
State/province [170] 0 0
Roma
Country [171] 0 0
Italy
State/province [171] 0 0
Rozzano
Country [172] 0 0
Italy
State/province [172] 0 0
Torino
Country [173] 0 0
Japan
State/province [173] 0 0
Ageo-shi
Country [174] 0 0
Japan
State/province [174] 0 0
Bunkyo-ku
Country [175] 0 0
Japan
State/province [175] 0 0
Chuo-ku
Country [176] 0 0
Japan
State/province [176] 0 0
Fukuoka-shi
Country [177] 0 0
Japan
State/province [177] 0 0
Hachioji
Country [178] 0 0
Japan
State/province [178] 0 0
Hiroshima-shi
Country [179] 0 0
Japan
State/province [179] 0 0
Jonan-ku
Country [180] 0 0
Japan
State/province [180] 0 0
Kawagoe
Country [181] 0 0
Japan
State/province [181] 0 0
Kitakyushu-shi
Country [182] 0 0
Japan
State/province [182] 0 0
Kofu-shi
Country [183] 0 0
Japan
State/province [183] 0 0
Kurume-shi
Country [184] 0 0
Japan
State/province [184] 0 0
Kyoto-shi
Country [185] 0 0
Japan
State/province [185] 0 0
Minato-ku
Country [186] 0 0
Japan
State/province [186] 0 0
Mitaka-shi
Country [187] 0 0
Japan
State/province [187] 0 0
Morioka-shi
Country [188] 0 0
Japan
State/province [188] 0 0
Nagakute-shi
Country [189] 0 0
Japan
State/province [189] 0 0
Nagasaki-shi
Country [190] 0 0
Japan
State/province [190] 0 0
Nagoya
Country [191] 0 0
Japan
State/province [191] 0 0
Nishi-ku
Country [192] 0 0
Japan
State/province [192] 0 0
Nishinomiya
Country [193] 0 0
Japan
State/province [193] 0 0
Oita-shi
Country [194] 0 0
Japan
State/province [194] 0 0
Okayama-city
Country [195] 0 0
Japan
State/province [195] 0 0
Osaka-City
Country [196] 0 0
Japan
State/province [196] 0 0
Osaka
Country [197] 0 0
Japan
State/province [197] 0 0
Otsu
Country [198] 0 0
Japan
State/province [198] 0 0
Saga-shi
Country [199] 0 0
Japan
State/province [199] 0 0
Saga
Country [200] 0 0
Japan
State/province [200] 0 0
Saitama
Country [201] 0 0
Japan
State/province [201] 0 0
Sakura
Country [202] 0 0
Japan
State/province [202] 0 0
Sapporo-shi
Country [203] 0 0
Japan
State/province [203] 0 0
Sendai
Country [204] 0 0
Japan
State/province [204] 0 0
Suita
Country [205] 0 0
Japan
State/province [205] 0 0
Takamatsu-shi
Country [206] 0 0
Japan
State/province [206] 0 0
Takasaki-shi
Country [207] 0 0
Japan
State/province [207] 0 0
Toyota-shi
Country [208] 0 0
Japan
State/province [208] 0 0
Wakayama-shi
Country [209] 0 0
Japan
State/province [209] 0 0
Yokohama-shi
Country [210] 0 0
Korea, Republic of
State/province [210] 0 0
Busan
Country [211] 0 0
Korea, Republic of
State/province [211] 0 0
Daegu
Country [212] 0 0
Korea, Republic of
State/province [212] 0 0
Guri-Si
Country [213] 0 0
Korea, Republic of
State/province [213] 0 0
Gyeonggi-do
Country [214] 0 0
Korea, Republic of
State/province [214] 0 0
Seongnam-si
Country [215] 0 0
Korea, Republic of
State/province [215] 0 0
Seoul
Country [216] 0 0
Korea, Republic of
State/province [216] 0 0
Suwon-si
Country [217] 0 0
Korea, Republic of
State/province [217] 0 0
Wonju
Country [218] 0 0
Malaysia
State/province [218] 0 0
Cheras
Country [219] 0 0
Malaysia
State/province [219] 0 0
George Town
Country [220] 0 0
Malaysia
State/province [220] 0 0
Kota Kinabalu
Country [221] 0 0
Malaysia
State/province [221] 0 0
Kuala Lumpur
Country [222] 0 0
Malaysia
State/province [222] 0 0
Kuantan
Country [223] 0 0
Netherlands
State/province [223] 0 0
Alkmaar
Country [224] 0 0
Netherlands
State/province [224] 0 0
Amsterdam
Country [225] 0 0
Netherlands
State/province [225] 0 0
Apeldoorn
Country [226] 0 0
Netherlands
State/province [226] 0 0
Groningen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Maastricht
Country [228] 0 0
Netherlands
State/province [228] 0 0
Rotterdam
Country [229] 0 0
Netherlands
State/province [229] 0 0
Tilburg
Country [230] 0 0
Netherlands
State/province [230] 0 0
Utrecht
Country [231] 0 0
New Zealand
State/province [231] 0 0
Christchurch
Country [232] 0 0
New Zealand
State/province [232] 0 0
Dunedin
Country [233] 0 0
New Zealand
State/province [233] 0 0
Grafton
Country [234] 0 0
New Zealand
State/province [234] 0 0
Hamilton
Country [235] 0 0
New Zealand
State/province [235] 0 0
Newtown
Country [236] 0 0
New Zealand
State/province [236] 0 0
Tauranga
Country [237] 0 0
New Zealand
State/province [237] 0 0
Wellington
Country [238] 0 0
Poland
State/province [238] 0 0
Bialystok
Country [239] 0 0
Poland
State/province [239] 0 0
Bydgoszcz
Country [240] 0 0
Poland
State/province [240] 0 0
Czestochowa
Country [241] 0 0
Poland
State/province [241] 0 0
Katowice
Country [242] 0 0
Poland
State/province [242] 0 0
Krakow
Country [243] 0 0
Poland
State/province [243] 0 0
Kraków
Country [244] 0 0
Poland
State/province [244] 0 0
Lodz
Country [245] 0 0
Poland
State/province [245] 0 0
Piotrków Trybunalski
Country [246] 0 0
Poland
State/province [246] 0 0
Poznan
Country [247] 0 0
Poland
State/province [247] 0 0
Rzeszów
Country [248] 0 0
Poland
State/province [248] 0 0
Sopot
Country [249] 0 0
Poland
State/province [249] 0 0
Szczecin
Country [250] 0 0
Poland
State/province [250] 0 0
Torun
Country [251] 0 0
Poland
State/province [251] 0 0
Tychy
Country [252] 0 0
Poland
State/province [252] 0 0
Warsaw
Country [253] 0 0
Poland
State/province [253] 0 0
Warszawa
Country [254] 0 0
Poland
State/province [254] 0 0
Wroclaw
Country [255] 0 0
Portugal
State/province [255] 0 0
Braga
Country [256] 0 0
Portugal
State/province [256] 0 0
Coimbra
Country [257] 0 0
Portugal
State/province [257] 0 0
Covilhã
Country [258] 0 0
Portugal
State/province [258] 0 0
Faro
Country [259] 0 0
Portugal
State/province [259] 0 0
Guimaraes
Country [260] 0 0
Portugal
State/province [260] 0 0
Loures
Country [261] 0 0
Portugal
State/province [261] 0 0
Porto
Country [262] 0 0
Portugal
State/province [262] 0 0
Viana do Castelo
Country [263] 0 0
Romania
State/province [263] 0 0
Bucharest
Country [264] 0 0
Romania
State/province [264] 0 0
Bucuresti
Country [265] 0 0
Romania
State/province [265] 0 0
Iasi
Country [266] 0 0
Romania
State/province [266] 0 0
Timisoara
Country [267] 0 0
Russian Federation
State/province [267] 0 0
Chelyabinsk
Country [268] 0 0
Russian Federation
State/province [268] 0 0
Irkutsk
Country [269] 0 0
Russian Federation
State/province [269] 0 0
Moscow
Country [270] 0 0
Russian Federation
State/province [270] 0 0
Nizhniy Novgorod
Country [271] 0 0
Russian Federation
State/province [271] 0 0
Novosibirsk
Country [272] 0 0
Russian Federation
State/province [272] 0 0
Saint-Petersburg
Country [273] 0 0
Russian Federation
State/province [273] 0 0
Saratov
Country [274] 0 0
Serbia
State/province [274] 0 0
Belgrade
Country [275] 0 0
Serbia
State/province [275] 0 0
Novi Sad
Country [276] 0 0
Singapore
State/province [276] 0 0
Singapore
Country [277] 0 0
Slovakia
State/province [277] 0 0
Bratislava
Country [278] 0 0
Slovakia
State/province [278] 0 0
Nitra
Country [279] 0 0
Slovakia
State/province [279] 0 0
Presov
Country [280] 0 0
South Africa
State/province [280] 0 0
Cape Town
Country [281] 0 0
South Africa
State/province [281] 0 0
Johannesburg
Country [282] 0 0
Spain
State/province [282] 0 0
Badalona
Country [283] 0 0
Spain
State/province [283] 0 0
Barcelona
Country [284] 0 0
Spain
State/province [284] 0 0
Ferrol
Country [285] 0 0
Spain
State/province [285] 0 0
Las Palmas de Gran Canaria
Country [286] 0 0
Spain
State/province [286] 0 0
Madrid
Country [287] 0 0
Spain
State/province [287] 0 0
Oviedo
Country [288] 0 0
Spain
State/province [288] 0 0
Pontevedra
Country [289] 0 0
Spain
State/province [289] 0 0
Sagunto
Country [290] 0 0
Spain
State/province [290] 0 0
Sevilla
Country [291] 0 0
Spain
State/province [291] 0 0
Usansolo
Country [292] 0 0
Sri Lanka
State/province [292] 0 0
Colombo
Country [293] 0 0
Sri Lanka
State/province [293] 0 0
Galle
Country [294] 0 0
Sri Lanka
State/province [294] 0 0
Kandy
Country [295] 0 0
Sri Lanka
State/province [295] 0 0
Ragama
Country [296] 0 0
Sweden
State/province [296] 0 0
Danderyd
Country [297] 0 0
Sweden
State/province [297] 0 0
Uppsala
Country [298] 0 0
Switzerland
State/province [298] 0 0
Bern
Country [299] 0 0
Switzerland
State/province [299] 0 0
Zurich
Country [300] 0 0
Taiwan
State/province [300] 0 0
Changhua
Country [301] 0 0
Taiwan
State/province [301] 0 0
Kaohsiung
Country [302] 0 0
Taiwan
State/province [302] 0 0
New Taipei City
Country [303] 0 0
Taiwan
State/province [303] 0 0
Taichung
Country [304] 0 0
Taiwan
State/province [304] 0 0
Tainan City
Country [305] 0 0
Taiwan
State/province [305] 0 0
Taipei
Country [306] 0 0
Taiwan
State/province [306] 0 0
Taoyuan
Country [307] 0 0
Ukraine
State/province [307] 0 0
Chernivtsi
Country [308] 0 0
Ukraine
State/province [308] 0 0
Dnipropetrovsk
Country [309] 0 0
Ukraine
State/province [309] 0 0
Ivano-Frankivsk
Country [310] 0 0
Ukraine
State/province [310] 0 0
Kharkiv
Country [311] 0 0
Ukraine
State/province [311] 0 0
Kropyvnytskyi
Country [312] 0 0
Ukraine
State/province [312] 0 0
Kyiv
Country [313] 0 0
Ukraine
State/province [313] 0 0
Odessa
Country [314] 0 0
Ukraine
State/province [314] 0 0
Ternopil
Country [315] 0 0
Ukraine
State/province [315] 0 0
Uzhgorod
Country [316] 0 0
Ukraine
State/province [316] 0 0
Vinnytsia
Country [317] 0 0
Ukraine
State/province [317] 0 0
Zaporizhzhya
Country [318] 0 0
United Kingdom
State/province [318] 0 0
Norfolk
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Birmingham
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Bury
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Cambridge
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Edinburgh
Country [323] 0 0
United Kingdom
State/province [323] 0 0
Exeter
Country [324] 0 0
United Kingdom
State/province [324] 0 0
Glasgow
Country [325] 0 0
United Kingdom
State/province [325] 0 0
High Wycombe
Country [326] 0 0
United Kingdom
State/province [326] 0 0
London
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Oxford
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Prescot
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galapagos NV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02914600