A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
- Registration Number
- NCT02641392
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.
The GED-0301-CD-003 trial was not initiated; see detailed description.
- Detailed Description
This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.
There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.
1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
4. continuous GED-0301 40 mg once daily through Week 208;
5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.
The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GED-0301 (160 mg) followed by Placebo intermittent 160 mg GED-0301 GED-0301 160 mg once daily (QD) for 12 weeks, followed by alternating Placebo (PBO) QD for 4 weeks with GED 0301 160 mg QD for 4 weeks, up to 208 weeks, if the subject previously received Placebo in the prior GED-0301 Study Intermittent GED-0301 160 mg and placebo GED-0301 Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study Intermittent GED-0301 160 mg and placebo Placebo Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study Intermittent placebo and GED-0301 40 mg Placebo Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study Continuous GED-0301 40 mg GED-0301 GED-0301 40 mg once daily (QD) for up to 208 weeks Intermittent placebo and GED-0301 160 mg GED-0301 Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208 Intermittent placebo and GED-0301 160 mg Placebo Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208 Intermittent placebo and GED-0301 40 mg GED-0301 Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (231)
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Military Medical Academy
🇷🇸Belgrade, Serbia
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Fakultna nemocnica s poliklinikou F. D. Roosevelta
🇸🇰Banska Bystrica, Slovakia
Istanbul University Cerrahpasa Medical Faculty Hospital
🇹🇷Istanbul, Turkey
ClinSearch LLC
🇺🇸Chattanooga, Tennessee, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Texas Digestive Disease Consultants - Southlake
🇺🇸Flower Mound, Texas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
UZ Leuven
🇧🇪Leuven, Belgium
Trial Management Associates LLC
🇺🇸Wilmington, North Carolina, United States
CHU Sart Tilman
🇧🇪Liege, Belgium
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Brandon Medical Arts Clinic
🇨🇦Brandon, Manitoba, Canada
Monash Medical Centre Clayton
🇦🇺Bentleigh East, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Texas Digestive Disease Consultants - Dallas
🇺🇸Dallas, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
MHAT Doverie AD
🇧🇬Sofia, Bulgaria
South Edmonton Gastroenterology
🇨🇦Edmonton, Alberta, Canada
Via Christi Research a division of Via Christi Hospitals Wichita Inc
🇺🇸Wichita, Kansas, United States
Ehrhardt Clinical Research LLC
🇺🇸Belton, Missouri, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
MHAT Ruse AD
🇧🇬Ruse, Bulgaria
City Clinic UMHAC EOOD
🇧🇬Sofia, Bulgaria
PreventaMed
🇨🇿Olomouc, Czechia
UMHAT Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
Toronto Digestive Disease Associates Inc
🇨🇦Vaughan, Ontario, Canada
Second MHAT Sofia AD
🇧🇬Sofia, Bulgaria
Clinical Hospital Centre Osijek
🇭🇷Osijek, Croatia
UMHAT Sv Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
University of Alberta
🇨🇦Edmonton, Alberta, Canada
CHU Nice Hopital de lArchet 2
🇫🇷Nice Cedex 3, France
CHU Tours Hopital Trousseau
🇫🇷Chambray les Tours, France
MHAT Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
CHU Clermont Ferrand
🇫🇷Clermont-Ferrand, France
Groupe Hospitalier Sud Hopital Haut Leveque USN
🇫🇷Pessac, France
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo FG, Italy
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Zuyderland Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Montfort Hospital
🇨🇦Ottawa, Ontario, Canada
Magyar Honvedseg Egeszsegugyi Kozpont
🇭🇺Budapest, Hungary
HaEmek Medical Center
🇮🇱Afula, Israel
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite cedex, France
CCBR Prague CZ
🇨🇿Praha 3, Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden
🇩🇪Dresden, Germany
CHU Reims Hopital Robert Debre
🇫🇷Reims, France
Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
🇩🇪Heidelberg, Germany
Fakultni nemocnice u sv Anny v Brne
🇨🇿Brno, Czechia
Azienda Ospedaliera Vincenzo Cervello
🇮🇹Palermo, Italy
DRK Kliniken Berlin Westend
🇩🇪Berlin, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
CHU Rennes Hopital Pontchaillou
🇫🇷Rennes cedex 09, France
Hopital Beaujon
🇫🇷Clichy cedex, France
Hopital de Brabois Adultes
🇫🇷Vandoeuvre les Nancy, France
CHA Bundang Medical Center CHA University
🇰🇷Seongnam-si,, Korea, Republic of
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Klinikum der Universitaet Muenchen
🇩🇪München, Germany
Athens Medical Center
🇬🇷Athens, Greece
Krankenhaus Waldfriede e V
🇩🇪Berlin, Germany
Semmelweis Egyetem AOK
🇭🇺Budapest, Hungary
CHU Strasbourg Hopital Hautepierre
🇫🇷Strasbourg Cedex, France
Rambam Health Care Campus
🇮🇱Haifa, Israel
Universitaetsklinikum Schleswig Holstein Campus Kiel
🇩🇪Kiel, Germany
DRC Gyogyszervizsgalo Kozpont Kft
🇭🇺Balatonfured, Hungary
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Clinfan Szolgaltato Kft
🇭🇺Szekszard, Hungary
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt, Germany
CI Odesa Regional Clinical Hospital
🇺🇦Odessa, Ukraine
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Asklepios Klinik Hamburg
🇩🇪Hamburg, Germany
Centrum Medyczne Medyk
🇵🇱Rzeszow, Poland
General Hospital of Athens Evangelismos
🇬🇷Athens, Greece
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
🇮🇹Rome, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Universitaetsklinikum Halle Saale
🇩🇪Halle, Germany
Kaplan Medical Center
🇮🇱Rechovot, Israel
CI Zaporizhzhia Regional Clinical Hospital of ZRC
🇺🇦Zaporozhje, Ukraine
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Endomedix Diagnosztikai Kozpont
🇭🇺Budapest, Hungary
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Universita Campus Bio Medico di Roma
🇮🇹Roma, Italy
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
The Baruch Padeh MC, Poriya
🇮🇱Tiberias, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Korea, Republic of
Petz Aladar Megyei Oktato Korhaz
🇭🇺Gyor, Hungary
SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
🇵🇱Lodz, Poland
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Indywidualna Praktyka Lekarska Maciej Zymla
🇵🇱Knurow, Poland
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
🇵🇱Kielce, Poland
SBHI of NN region RCH of NN n.a. N.A.Semashko
🇷🇺Nizhny Novgorod, Russian Federation
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Metropolitan Gastroenterology
🇺🇸Chevy Chase, Maryland, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
University General Hospital of Patras
🇬🇷Rio Patras, Greece
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
Medical Associates Research Group Inc.
🇺🇸San Diego, California, United States
Sagact Pllc
🇺🇸San Antonio, Texas, United States
Aarhus Universitetshospital
🇩🇰Aahus C, Denmark
Alborg Universitets Hospital
🇩🇰Alborg, Denmark
Nordsjaellands Hospital Frederikssund
🇩🇰Frederikssund, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Koge Sygehus
🇩🇰Koge, Denmark
Regionshospitalet Silkeborg
🇩🇰Silkeborg, Denmark
McMaster University Health Sciences Center
🇨🇦Hamilton, Ontario, Canada
LHSC Victoria Hospital
🇨🇦London, Ontario, Canada
Medicine Professional Corporation
🇨🇦Waterloo, Ontario, Canada
McGill University Health Centre Glen Site Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
PerCuro Clinical Research
🇨🇦Victoria, British Columbia, Canada
KH der Barmherzigen Brüder St.Veit an der Glan
🇦🇹St Veit An Der Glan, Austria
AKH Medizinische Universitat Wien
🇦🇹Wein, Austria
KH der Barmherzigen Bruder Linz
🇦🇹Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
🇦🇹Salzburg, Austria
LKH Universitaetsklinikum Graz
🇦🇹Graz, Austria
Krankenanstalt Rudolfstiftung Wien
🇦🇹Wein, Austria
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
Akershus universitetssykehus HF
🇳🇴Lørenskog, Norway
GASTRO I., s.r.o.
🇸🇰Presov, Slovakia
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Clinical Center Zvezdara
🇷🇸Belgrade, Serbia
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Digestive Diseases Center Gastro
🇱🇻Riga, Latvia
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
KM Management, spol. s r.o.
🇸🇰Nitra, Slovakia
Clinical Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
🇸🇰Malacky, Slovakia
Oslo Universitetssykehus Rikshospitalet
🇳🇴Oslo, Norway
Centrul de Gastroenterologie Dr. Goldis
🇷🇴Timisoara, Romania
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
CHU de Toulouse Hopital Rangueil
🇫🇷Toulouse Cedex 09, France
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
University Leipzig
🇩🇪Leipzig, Germany
Medizinisches Zentrum Klinikum Lueneburg
🇩🇪Lueneburg, Germany
Gastro Campus Research
🇩🇪Muenster, Germany
Klinikum Mannheim GmbH Universitaetsklinikum
🇩🇪Mannheim, Germany
Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
🇩🇪Niedersachsen, Germany
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Evromedservis
🇷🇺Pushkin, Russian Federation
SBEIHPE Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Hadassah University Hospital
🇮🇱Jerusalem, Israel
FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
🇷🇺Novosibirsk, Russian Federation
Health Science Research Center, LLC
🇺🇸Pratt, Kansas, United States
Gastroenterology Associates LLC
🇺🇸Baton Rouge, Louisiana, United States
Gastroenterology Associates of Western Michigan PLC
🇺🇸Wyoming, Michigan, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Texas Clinical Research Institute LLC
🇺🇸Arlington, Texas, United States
Centre For Digestive Diseases
🇦🇺Five Dock, New South Wales, Australia
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
CHU Amiens Hopital Sud
🇫🇷Amiens Cedex, France
University of Calgary
🇨🇦Calgary, Alberta, Canada
GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Centre de sante et de services sociaux Champlain Charles Le Moyne
🇨🇦Greenfield Park, Quebec, Canada
Hepato-Gastroenterologie HK
🇨🇿Hradec Kralove, Czechia
London Health Science Center U. Hospital
🇨🇦London, Ontario, Canada
CHU Nantes Hotel Dieu
🇫🇷Nantes Cedex 1, France
CHU Saint Etienne Hopital Nord
🇫🇷Saint Etienne, France
CHU Besancon Hopital Jean Minjoz
🇫🇷Besancon Cedex, France
Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
🇩🇪Berlin, Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
🇩🇪Bochum, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Germany
University General Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
🇭🇺Dunaujvaros, Hungary
Tel Aviv Sourasky Medical Center Department of Hematology
🇮🇱Tel Aviv, Israel
Azienda Ospedaliera Universitaria Policlinico G Martino
🇮🇹Messina, Italy
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
🇮🇹Bologna, Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Hospital da Senhora da Oliveira Guimaraes
🇵🇹Guimaraes, Portugal
CMI Dr. Tirnaveanu Amelita
🇷🇴Oradea, Romania
S.C MedLife S.A
🇷🇴Bucuresti, Romania
TSBIH Territorial Clinical Hospital
🇷🇺Krasnoyarsk, Russian Federation
SEIHPE Rostov State Medical University of MoH of RF
🇷🇺Rostov-on-Don, Russian Federation
SPb SBIH City Hospital # 26
🇷🇺Saint-Petersburg, Russian Federation
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
🇷🇺Samara, Russian Federation
Alian s.r.o.
🇸🇰Bardejov, Slovakia
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Corporacion Sanitaria Parc Tauli
🇪🇸Sabadell, Spain
Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
🇨🇭Bern, Switzerland
Danderyds Sjukhus AB
🇸🇪Stockholm, Sweden
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Yeditepe University Medical School Hospital
🇹🇷Istanbul, Turkey
Acibadem Fulya Hospital
🇹🇷Istanbul, Turkey
Haydarpasa Numune Training and Research Hospital
🇹🇷Istanbul, Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
🇹🇷Istanbul, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Turkey
Kocaeli Derince Training and Research Hospital
🇹🇷Kocaeli, Turkey
RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
🇺🇦Chernivtsi, Ukraine
CI of PH Kharkiv CCH #2
🇺🇦Kharkiv, Ukraine
Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
🇺🇦Kirovohrad, Ukraine
Kyiv City Clinical Hospital #1
🇺🇦Kyiv, Ukraine
Royal Devon and Exeter Hospital Wonford
🇬🇧Exeter, United Kingdom
Ternopil City Communal Emergency Medical Care Hospital
🇺🇦Ternopil, Ukraine
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Nottingham University Hospitals Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
St Marys Hospital
🇬🇧London, United Kingdom
Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
🇺🇦Kyiv, Ukraine
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
🇺🇦Kyiv, Ukraine