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



Status:Active, not recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:4/3/2019
Start Date:January 9, 2017
End Date:September 30, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

1. 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.

2. 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.

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

Exclusion Criteria:

1. There are no exclusion criteria for this study.
We found this trial at
16
sites
UCSF Benioff Children's Hospital
San Francisco, California 94143
Principal Investigator: Sue Rhee
Phone: 415-476-2385
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San Francisco, CA
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Samuel Kocoshis
Phone: 513-636-0137
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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University of Wisconsin School of Medicine and Public Health
750 Highland Avenue
Madison, Wisconsin 53792
Principal Investigator: Peter Nichol
Phone: 608-262-9799
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Madison, WI
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Natalie Terry
Phone: 215-590-6853
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Raphael Bram
Phone: 617-919-3619
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Children's Hospital at Montefiore
Bronx, New York 10467
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Bronx, NY
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Cliniques Universitaires Saint-Luc
10 Avenue Hippocrate
Bruxelles, Woluwe-Saint-Lambert 1200
Principal Investigator: Dominique Hermans
Phone: +3227641389
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Bruxelles,
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Duke Medical Center
Durham, North Carolina 27708
Principal Investigator: Debra Sudan
Phone: 919-681-6898
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Durham, NC
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Texas Children's Hospital
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Beth Carter, MD
Phone: 832-824-3634
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Riley Hospital for Children
705 Riley Hospital Drive
Indianapolist, Indiana 46202
Principal Investigator: Charles Vanderpool
Phone: 317-944-4490
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Indianapolist, IN
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Children's Hospital Los Angeles - RHU
Los Angeles, California 90027
Principal Investigator: Russell Merritt
Phone: 323-361-8631
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Los Angeles, CA
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Mattel Children's Hospital at UCLA
Los Angeles, California 90095
Principal Investigator: Robert Venick, MD
Phone: 310-825-4349
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Los Angeles, CA
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Columbia Unversity Medical Center
630 West 168th Street
New York, New York 07024
Principal Investigator: Mercedes Martinez
Phone: 212-305-3839
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New York, NY
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Nebraska Medical Center
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Principal Investigator: David Mercer
Phone: 402-559-2556
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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Omaha, NE
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Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Simon Horslen
Phone: 206-987-0055
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Georgetown Children's Research Network
Washington, District of Columbia 20007
Principal Investigator: Stuart Kaufman
Phone: 202-444-1769
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Washington,
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