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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02620046
Registration number
NCT02620046
Ethics application status
Date submitted
19/11/2015
Date registered
2/12/2015
Titles & IDs
Public title
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
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Scientific title
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease
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Secondary ID [1]
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0
U1111-1168-0921
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Secondary ID [2]
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MLN0002SC-3030
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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0
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Crohn's Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab SC
Experimental: Group A: Vedolizumab SC 108 mg Q2W - Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who:
* Completed the Maintenance Period (Week 52), or
* Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.
Experimental: Group B: Vedolizumab SC 108 mg QW - Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure.
•Participants from current study who experience treatment failure while on study.
Treatment: Drugs: Vedolizumab SC
Vedolizumab SC 108 mg injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
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Assessment method [1]
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Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.
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Timepoint [1]
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From start of study medication through 18 weeks after the last dose
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Secondary outcome [1]
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Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
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Assessment method [1]
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Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
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Timepoint [1]
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From start of study medication through 18 weeks after the last dose
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Secondary outcome [2]
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Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response
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Assessment method [2]
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Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and =25% from baseline, with an accompanying decrease in rectal bleeding subscore of =1 point from baseline or absolute rectal bleeding subscore of =1 point.
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Timepoint [2]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Secondary outcome [3]
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Percentage of Participants with Crohn's Disease Achieving Clinical Response
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Assessment method [3]
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Clinical response is defined as a decrease in HBI score of =3 points from baseline in CD participants (randomized early terminator CD participants only \[defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52\]).
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Timepoint [3]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Secondary outcome [4]
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Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission
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Assessment method [4]
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Clinical remission is defined as a partial Mayo score of = 2 with no individual subscore \>1.
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Timepoint [4]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
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Secondary outcome [5]
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Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission
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Assessment method [5]
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Clinical remission is defined as total HBI score of =4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).
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Timepoint [5]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Eligibility
Key inclusion criteria
1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/04/2024
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Sample size
Target
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Accrual to date
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Final
746
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Tennyson Centre Day Hospital - Kurralta Park
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Clayton - Bentleigh East
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St Vincent's Hospital Melbourne - Fitzroy
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St Frances Xavier Cabrini Hospital - Malvern
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Royal Melbourne Hospital - Melbourne
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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St John of God Subiaco Hospital - Subiaco
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2139 - Concord
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2747 - Kingswood
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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Recruitment postcode(s) [6]
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5037 - Kurralta Park
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3350 - Ballarat
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Recruitment postcode(s) [8]
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3165 - Bentleigh East
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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3144 - Malvern
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Recruitment postcode(s) [11]
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3000 - Melbourne
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Recruitment postcode(s) [12]
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3181 - Melbourne
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment postcode(s) [14]
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6008 - Subiaco
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Recruitment outside Australia
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Japan
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State/province [110]
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0
Hyogo-Ken
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Country [111]
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Japan
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State/province [111]
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Iwate-Ken
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Country [112]
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0
Japan
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State/province [112]
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0
Kagawa-Ken
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Country [113]
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Japan
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State/province [113]
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0
Kanagawa-Ken
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Country [114]
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Japan
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State/province [114]
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0
Okayama-Ken
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Country [115]
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0
Japan
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State/province [115]
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0
Osaka-Fu
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Country [116]
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Japan
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State/province [116]
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0
Saga-Ken
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Country [117]
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Japan
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State/province [117]
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0
Shiga-Ken
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Country [118]
0
0
Japan
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State/province [118]
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0
Shizuoka-Ken
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Country [119]
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0
Japan
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State/province [119]
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0
Tokyo-To
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Country [120]
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0
Japan
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State/province [120]
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0
Wakayama-Ken
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Country [121]
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Korea, Republic of
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State/province [121]
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Gyeongsangbuk-do
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Country [122]
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Korea, Republic of
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State/province [122]
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Daegu
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Country [123]
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Korea, Republic of
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State/province [123]
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Seoul
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Country [124]
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0
Lithuania
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State/province [124]
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Kaunas
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Country [125]
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Lithuania
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State/province [125]
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Klaipeda
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Country [126]
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Lithuania
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State/province [126]
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0
Vilnius
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Country [127]
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Mexico
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State/province [127]
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Guanajuato
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Country [128]
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Mexico
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State/province [128]
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Jalisco
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Country [129]
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Mexico
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State/province [129]
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Nuevo Leon
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Country [130]
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Mexico
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Durango
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Country [131]
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Mexico
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State/province [131]
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Veracruz
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Country [132]
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0
Netherlands
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State/province [132]
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Amsterdam
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Netherlands
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State/province [133]
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Dordrecht
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Netherlands
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State/province [134]
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Groningen
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Country [135]
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Netherlands
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State/province [135]
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Maastricht
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Country [136]
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Netherlands
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State/province [136]
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Rotterdam
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Poland
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State/province [137]
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Bialystok
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Country [138]
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Poland
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Bydgoszcz
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Country [139]
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Poland
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Katowice
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Poland
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State/province [140]
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Krakow
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Country [141]
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Poland
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State/province [141]
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Lodz
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Country [142]
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Poland
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State/province [142]
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Lublin
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Country [143]
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Poland
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State/province [143]
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Szczecin
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Country [144]
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Poland
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State/province [144]
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Warszawa
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Poland
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Wroclaw
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Country [146]
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Romania
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State/province [146]
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Bucuresti
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Romania
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State/province [147]
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Timisoara
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Country [148]
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Russian Federation
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State/province [148]
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Kazan
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Country [149]
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Russian Federation
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State/province [149]
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Krasnoyarsk
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Russian Federation
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Moscow
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Country [151]
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Russian Federation
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State/province [151]
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Novosibirsk
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Country [152]
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Russian Federation
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State/province [152]
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Omsk
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Country [153]
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Russian Federation
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Rostov-on-Don
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Country [154]
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Russian Federation
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State/province [154]
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Saint-Petersburg
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Country [155]
0
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Russian Federation
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State/province [155]
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Sestroretsk
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Country [156]
0
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Russian Federation
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State/province [156]
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St. Petersburg
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Country [157]
0
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Serbia
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State/province [157]
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0
Belgrade
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Country [158]
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Serbia
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State/province [158]
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Kragujevac
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Country [159]
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Serbia
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State/province [159]
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Nis
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Country [160]
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Serbia
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State/province [160]
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0
Novi Sad
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Country [161]
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Slovakia
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Banska Bystrica
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Country [162]
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Slovakia
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State/province [162]
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Bratislava
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Country [163]
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Slovakia
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State/province [163]
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Kosice
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Country [164]
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Slovakia
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State/province [164]
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Nitra
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Country [165]
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Slovakia
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Presov
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Country [166]
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South Africa
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Gauteng
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Country [167]
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South Africa
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State/province [167]
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Western Cape
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Country [168]
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0
Spain
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State/province [168]
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0
Barcelona
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Country [169]
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Spain
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State/province [169]
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Madrid
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Country [170]
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Spain
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State/province [170]
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Alicante
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Country [171]
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Spain
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State/province [171]
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Girona
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Country [172]
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Spain
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State/province [172]
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Pontevedra
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Country [173]
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Sweden
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State/province [173]
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Stockholm
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Country [174]
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Taiwan
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Taipei
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Country [175]
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Turkey
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Ankara
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Country [176]
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Turkey
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State/province [176]
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Istanbul
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Country [177]
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Turkey
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State/province [177]
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Kocaeli
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Country [178]
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Turkey
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State/province [178]
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Mersin
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Country [179]
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Ukraine
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State/province [179]
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Chernivtsi
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Country [180]
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Ukraine
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State/province [180]
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Dnipro
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Country [181]
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Ukraine
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Ivano-Frankivsk
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Country [182]
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Ukraine
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Kharkiv
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Country [183]
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Ukraine
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Kherson
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Country [184]
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Ukraine
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State/province [184]
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Kyiv
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Country [185]
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Ukraine
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State/province [185]
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Lviv
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Country [186]
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Ukraine
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State/province [186]
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Odesa
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Country [187]
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Ukraine
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State/province [187]
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Ternopil
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Country [188]
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Ukraine
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State/province [188]
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Vinnytsia
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Country [189]
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Ukraine
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Zaporizhzhia
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Country [190]
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United Kingdom
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Devon
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Country [191]
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United Kingdom
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0
Greater London
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Country [192]
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United Kingdom
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Norfolk
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Country [193]
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United Kingdom
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0
Shropshire
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Country [194]
0
0
United Kingdom
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State/province [194]
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.
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Trial website
https://clinicaltrials.gov/study/NCT02620046
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director Clinical Science
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Address
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0
Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02620046