A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Status:
Completed
Trial end date:
2015-01-09
Target enrollment:
Participant gender:
Summary
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.