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

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)