Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

PHASE3CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 18, 2014

Primary Completion Date

November 5, 2018

Study Completion Date

November 5, 2018

Conditions
Short Bowel Syndrome
Interventions
DRUG

Teduglutide

0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.

Trial Locations (5)

980-8574

Tohoku University Hospital, Sendai

240-8555

Yokohama Municipal Citizen's Hospital, Yokohama

663-8501

Hospital of Hyogo College of Medicine, Hyōgo

565-0871

Osaka University Hospital, Department of Gastroenterological Surgery, Osaka

Osaka University Hospital, Department of Pediatric Surgery, Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT02340819 - Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS) | Biotech Hunter | Biotech Hunter