Detail of the clinical trial

Title of the trial An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn?s Disease and Active Ulcerative Colitis
EudraCT number 2016-002124-89
Protocol number CT-P13-1.6
Sponsor Celltrion, Inc,23, Academy-ro,Yeonsu-gu, Incheon, 22014, Republic of Korea
Indications Internal medicine
Diagnosis Active Crohn´s Disease and Active Ulcerative Colitis
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2018
Date of approval by Institute (SÚKL) 27.4.2018
Date of approval by EC 26.4.2018
Date of initiation CT in ČR 25.7.2018
Date of ending CT in ČR 19.12.2019
Notice
Sites Fakultní nemocnice Ostrava,Interní oddělení,17. listopadu 1790,Ostrava-Poruba ,708 52

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