A research study to learn how safe, efficacious and tolerated over 24 weeks of time teduglutide (the study medication) is when given to paediatric patients of up to 17 years of age who are suffering from short bowel syndrome.
- Registry ID
- EUCTR2015-002252-27
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- NPS Pharmaceuticals, Inc.
- Start date
- 2016-05-23
- Completion date
- 2017-08-18
- Last update
- 2026-08-16
Conditions
Summary
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy/pharmacodynamics of teduglutide in pediatric subjects (through 17 years) with SBS who are dependent on parenteral support.
Locations
- , , UK
- , , Italy
- , , Belgium
- , , Finland
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- A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)
- Resting Energy Expenditure by Gastrointestinal Functional Status
View on source registry