Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

July 6, 2018

Primary Completion Date

August 6, 2019

Study Completion Date

August 6, 2019

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 Pharmaceuticals and Medical Devices Agency (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

Shire

INDUSTRY

NCT03663582 - Study of Teduglutide in Japanese Participants With Short Bowel Syndrome | Biotech Hunter | Biotech Hunter