NCT05027308

A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who Are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Older, and Requiring the Dosing of 1.25 mg Formulation

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

Summary

The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks. Participants may be able to repeat this treatment if they meet specific criteria. The study doctors will check for side effects from teduglutide until it becomes commercially available. The maximum duration of treatment is approximately 51.3 weeks.

Detailed description

A study of teduglutide in Japanese children with short bowel syndrome aged 4 months or older.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	Teduglutide 0.05 mg/kg SC injection

Timeline

• Start date: 2022-01-04
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2021-08-30
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

6 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study