Trial intelligence / Profile preview

Teduglutide Extension Study for Japanese SBS Patients

NCT03596164Phase 3Completed

Sponsor
Takeda
Start
Jul 2018
Primary completion
Jan 2022
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 Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at 40.2 months, Change From Baseline in Weekly PS Volume at 40.2 months and 9 more. Started Jul 2018; status: completed.

02

Drugs

teduglutide
03

Conditions

short bowel syndrome (SBS)

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