Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study.

ABSTRACT:

Background

Patients with short bowel syndrome (SBS)-associated intestinal failure (SBS-IF) are dependent on parenteral support (PS). In Japan, teduglutide is the only GLP-2 analog medicine indicated for these patients. There are limited data for pediatric patients, especially those with a low body weight. This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.

Methods

This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF. Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up). Adverse events

SUBMITTER: Masumoto K 

PROVIDER: S-EPMC12743259 | biostudies-literature | 2026 Jan-Dec

REPOSITORIES: biostudies-literature