drugset / Trial / NCT03596164

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

NCT03596164

Phase 3 Completed 11 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

Timeline

Start
2018-07-09
Primary completion
2022-01-13
Completion
2022-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 0.05 mg/kg Subcutaneous

Indications