NCT03571516

Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

A Randomized, Open-label, 24-Week Safety, Efficacy, and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 4 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.
OTHER	Standard Medical Therapy	Standard medical therapy will be administered for 24 weeks.
DEVICE	Syringe	Teduglutide will be administered using syringe (510k number: K980987).
DEVICE	Needle	Teduglutide will be administered using needle (510k number: K021475).

Timeline

• Start date: 2018-08-31
• Primary completion: 2020-09-24
• Completion: 2020-09-24
• First posted: 2018-06-27
• Last updated: 2021-05-11
• Results posted: 2021-04-08

Locations

8 sites across 4 countries: Finland, France, Italy, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study