7
Participants
Start Date
July 6, 2018
Primary Completion Date
August 6, 2019
Study Completion Date
August 6, 2019
Teduglutide
Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
Syringe
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).
Needle
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Vial Adapter for Device
Vial adapter for device is approved for use in Japan by PMDA.
Hiroshima University Hospital, Hiroshima
Hyogo College of Medicine Hospital, Hyōgo
Tohoku University Hospital, Miyagi-Ken
Osaka University Hospital, Osaka
Yokohama Municipal Citizen's Hospital, Yokohama
Lead Sponsor
Shire
INDUSTRY