drugset / Trial / NCT02682381

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

NCT02682381

Phase 3 Completed 59 enrolled Shire
RandomizedSingle-groupTriple-blindTreatment

Summary

Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

Timeline

Start
2016-06-23
Primary completion
2017-08-18
Completion
2017-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 0.025 mg/kg
Subject Teduglutide Peptide 0.05 mg/kg

Indications