An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

PHASE3CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 9, 2018

Primary Completion Date

January 13, 2022

Study Completion Date

January 13, 2022

Conditions
Short Bowel Syndrome
Interventions
DRUG

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.

DEVICE

Syringe

Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.

DEVICE

Needle

Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.

DEVICE

Vial Adapter for Device

Vial adapter for device is approved for use in Japan by PMDA.

Trial Locations (5)

734-8551

Hiroshima University Hospital, Hiroshima

663-8501

Hyogo College of Medicine Hospital, Hyōgo

980-8574

Tohoku University Hospital, Miyagi-Ken

565-0871

Osaka University Hospital, Osaka

240-8555

Yokohama Municipal Citizen's Hospital, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY