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

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.

Timeline

Start

2022-01-04

Primary completion

2023-09-27

Completion

2023-09-27

Publications

• Masumoto K, Muto M, Sasaki T, Shikamura M, Tanaka T, Sakui S, Miyamoto M, Nakano H, Kondo T, Ieiri S. Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study. Pediatr Int. 2026 Jan-Dec;68(1):e70301. doi: 10.1111/ped.70301.

Drugs

Indications