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Long-term Safety and Efficacy of Teduglutide in Japanese Pediatric SBS
NCT03268811Phase 3Completed
- Sponsor
- Takeda
- Start
- Aug 2017
- Primary completion
- Nov 2021
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of teduglutide in short bowel syndrome (SBS), sponsored by Takeda. Primary endpoints: Number of Participants With Treatment-emergent Adverse Events up to 50 months, Number of Participants With Clinically Significant Abnormalities in Vital Signs up to 50 months and 12 more. Started Aug 2017; status: completed.
02
Drugs
teduglutide
03
Conditions
short bowel syndrome (SBS)
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