Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

January 9, 2017

Primary Completion Date

November 5, 2020

Study Completion Date

November 5, 2020

Conditions
Short Bowel Syndrome
Interventions
DRUG

TED

0.05 mg/kg SC injection once daily.

OTHER

SOC

Standard safety assessments and adjustments in nutritional support.

DEVICE

Syringe

Teduglutide will be administered using syringe.

DEVICE

Needle

Teduglutide will be administered using needle.

Trial Locations (22)

1200

Cliniques Universitaires Saint-Luc, Brussels

19104

Children's Hospital of Philadelphia, Philadelphia

20007

Georgetown Children's Research Network, Washington D.C.

27710

Duke Medical Center, Durham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

53792

University of Wisconsin School of Medicine and Public Health, Madison

68198

The Nebraska Medical Center, Omaha

77030

Texas Children's Hospital, Houston

90095

Mattel Children's Hospital UCLA, Los Angeles

98105

Seattle Children's Hospital, Seattle

90027-6062

Childrens Hospital Los Angeles - RHU, Los Angeles

94158-2531

UCSF Benioff Children's Hospital, San Francisco

02115

Boston Children's Hospital, Boston

07024

Columbia Unversity Medical Center, New York

10467-2403

Children's Hosp. at Montefiore, The Bronx

T6G 1C9

Walter C. Mackenzie Health Science Centre, Edmonton

M5G 1X8

The Hospital for Sick Children, Toronto

00290

Helsingin yliopistollinen keskussairaala, Helsinki

00165

Ospedale Pediatrico Bambino Gesu, Roma

WC1N 3JH

Great Ormond Children's Hosp, London

B4 6NH

Birmingham Children's Hospital, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY