Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Ulcerative Colitis
Спонсор: Alfasigma S.p.A.
Налично на:
БГ
Обобщение
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 filgotinib treatment study in ulcerative colitis (UC).
Кой може да участва
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 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
* Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
* Females of childbearing potential must have a negative pregnancy test at Day 1
* Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 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
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
* Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Места на провеждане
36
Argentina (1)
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata
Австралия (1)
Monash Medical Centre
Clayton , New South Wales
Белгия (1)
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp
България (1)
MHAT Sveti Pantaleymon- Pleven OOD
Pleven
Канада (1)
University of Calgary, Heritage Medical Research Clinic
Calgary , Alberta
Хърватия (1)
Clinical Hospital Dubrava
Zagreb
Чехия (1)
Hepato-Gastroenterology HK, s.r.o.
Hradec Králové
Франция (1)
CHU Amiens Picardie
Amiens
Georgia (1)
Unimed Ajara LLC - Batumi Referral Hospital
Batumi
Германия (1)
Universitatsklinikum Schleswig-Holstein
Kiel , Schleswig-Holstein
Гърция (1)
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens
Hong Kong (1)
Princess Margaret Hospital
Hong Kong
Унгария (1)
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba
Индия (1)
Kaizen Hospital
Ahmedabad
Ireland (1)
Beaumont Hospital
Dublin
Израел (1)
Bnai Zion Medical Center
Haifa
Италия (1)
UOC Gastroenterologia II
Castellana Grotte
Япония (1)
Nagasaki University Hospital
Nagasaki , Nagasaki
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli
Нидерландия (1)
Academic Medical Center (AMC)
Amsterdam
New Zealand (1)
Christchurch Hospital
Christchurch
Полша (1)
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok
Румъния (1)
MedLife, Gastroenterologie
Bucharest
Russia (1)
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk
Сърбия (1)
Zvezdara University Medical Center
Belgrade
Сингапур (1)
Singapore General Hospital
Singapore
Словакия (1)
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
South Africa (1)
Dr MJ Prins
Cape Town
Южна Корея (1)
The Catholic University of Korea, St. Vincent's Hospital
Suwon , Gyeonggi-do
Испания (1)
Centro Medico Teknon
Barcelona
Швеция (1)
Skane University Hospital
Malmo
Taiwan (1)
Changhua Christian Hospital
Changhua
Ukraine (1)
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy
Великобритания (1)
Norfolk and Norwich University Hospital NHS Foundation Trust