A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:1 - 17
Updated:1/17/2019
Start Date:November 14, 2013
End Date:January 9, 2015

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A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide
in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into
an observational cohort who will receive standard of care. Three doses of teduglutide are to
be investigated for 12 weeks. All subjects will be screened prior to the start of treatment
(SOT) to establish baseline characteristics including safety, eligibility and nutritional
support parameters.


Key Inclusion Criteria:

- Current history of SBS as a result of major intestinal resection, (eg, due to
necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for
at least 12 months prior to screening

- Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support

- Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion
of the investigator

Key Exclusion Criteria:

- Serial transverse enteroplasty or any other bowel lengthening procedure performed
within the past 3 months

- Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known
DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome)

- Evidence of obstruction on upper gastrointestinal (GI) series done within 6 months
prior to screening

- Major gastrointestinal surgical intervention within 3 months prior to screening
(insertion of feeding tube or endoscopic procedure is allowed)
We found this trial at
19
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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Ann Arbor, MI
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Birmingham, Alabama 35233
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
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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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Kansas City, MO
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London,
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Los Angeles, CA
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Madison, WI
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Memphis, TN
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Nashville, TN
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Orlando, Florida 32806
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Seattle, WA
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