A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301

Status: Completed
Location: See all (22) locations...
Intervention Type: Drug, Device, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.

• Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.

• Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Locations
United States
California
Childrens Hospital Los Angeles - RHU
Los Angeles
Mattel Children's Hospital UCLA
Los Angeles
UCSF Benioff Children's Hospital
San Francisco
Washington, D.c.
Georgetown Children's Research Network
Washington
Indiana
Riley Hospital for Children
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
North Carolina
Duke Medical Center
Durham
Nebraska
The Nebraska Medical Center
Omaha
New York
Children's Hosp. at Montefiore
Bronx
Columbia Unversity Medical Center
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Texas
Texas Children's Hospital
Houston
Washington
Seattle Children's Hospital
Seattle
Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles
Canada
Walter C. Mackenzie Health Science Centre
Edmonton
The Hospital for Sick Children
Toronto
Finland
Helsingin yliopistollinen keskussairaala
Helsinki
Italy
Ospedale Pediatrico Bambino Gesu
Roma
United Kingdom
Birmingham Children's Hospital
Birmingham
Great Ormond Children's Hosp
London
Time Frame
Start Date: 2017-01-09
Completion Date: 2020-11-05
Participants
Target number of participants: 61
Treatments
Experimental: Standard of care (SOC) treatment +/- teduglutide (TED)
Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.
Related Therapeutic Areas
Sponsors
Leads: Shire

This content was sourced from clinicaltrials.gov