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

PHASE3CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 14, 2013

Primary Completion Date

January 9, 2015

Study Completion Date

January 9, 2015

Conditions
Short Bowel Syndrome
Interventions
DRUG

teduglutide

Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study

Trial Locations (19)

10467

Montefiore Medical Center, The Bronx

32806

Arnold Palmer Hospital for Children, Orlando

35233

Children´s Hospital of Alabama, Birmingham

37232

Monroe Carell, Jr. Children's Hospital at Vanderbilt, Nashville

38103

University of Tennessee Health Science Center Le Bonheur Pediatric Specialists, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children at IU Health, Indianapolis

48109

Mott Children's Hospital, University of Michigan, Ann Arbor

53792

University of Wisconsin School of Medicine and Public Health Surgery, Madison

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

64108

Childrens Mercy Hospitals & Clinics Pediatric Gastroenterology, Kansas City

68198

University of Nebraska Medical Center, Omaha

72202

Arkansas Children's Hospital, Little Rock

77030

Texas Children's Hospital, Baylor College of Medicine, Houston

90024

Children's Hospital Los Angeles, Los Angeles

90095

Mattel Children's Hospital UCLA, Department of Pediatric Gastroenterology, Los Angeles

98105

Seattle Childrens Hospital Gastroenterology and Hepatology, Seattle

02115

Boston Children's Hospital, Boston

Unknown

Great Ormond Street Hospital for Children, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY