NCT03663582

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

A 24-Week Safety, Efficacy, Pharmacokinetic Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Are Dependent on Parenteral Support

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous (PN/IV) over a 24-week treatment period.

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 Pharmaceuticals and Medical Devices Agency (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: 2018-07-06
• Primary completion: 2019-08-06
• Completion: 2019-08-06
• First posted: 2018-09-10
• Last updated: 2020-08-04
• Results posted: 2020-08-04

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study