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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
DEVICE	Syringe	Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
DEVICE	Needle	Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
DEVICE	Vial Adapter for Device	Vial adapter for device is approved for use in Japan by PMDA.

Timeline

• Start date: 2018-07-09
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2018-07-23
• Last updated: 2023-03-15
• Results posted: 2023-03-15

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study