Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/3/2019 |
| Start Date: | December 9, 2016 |
| End Date: | September 30, 2019 |
A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003
The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of
children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term
period. It will evaluate how these children fared after the TED-C13-003 study ended. This
study will also offer teduglutide treatment to eligible subjects, regardless of treatment
received in TED-C13-003.
children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term
period. It will evaluate how these children fared after the TED-C13-003 study ended. This
study will also offer teduglutide treatment to eligible subjects, regardless of treatment
received in TED-C13-003.
Inclusion Criteria:
1. Subject provides written informed consent (subject, parent or legal guardian and, as
appropriate, subject informed assent) to participate in the study before completing
any study-related procedures.
2. Subject completed the TED-C13-003 study (including subjects in the standard of care
treatment arm).
3. Subject understands and is willing and able to fully adhere to study requirements as
defined in this protocol.
Exclusion Criteria:
There are no exclusion criteria for this study.
We found this trial at
11
sites
750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Principal Investigator: Peter Nichol, MD
Phone: 608-262-9799
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Christopher Duggan, MD
Phone: 617-919-6289
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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6621 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Beth Carter
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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705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Charles Vanderpool, MD
Phone: 317-944-9605
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Kansas City, Missouri 64108
Principal Investigator: Joel Lim, MD
Phone: 816-802-1167
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London, WC1N 3JH
Principal Investigator: Susan Hill
Phone: + 44 (0) 20 7 813 8523
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Los Angeles, California 90027
Principal Investigator: Russell Merritt, MD
Phone: 323-361-8631
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Los Angeles, California 90095
Principal Investigator: Robert Venick, MD
Phone: 310-825-4349
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Simon Horslen, MD
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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