Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061766) titled 'Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan' on June 2.

Study Type: Observational

Primary Sponsor: Institute - Takeda Pharmaceutical Company Limited

Condition: Condition - Short Bowel Syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to retrospectively collect and analyze actual clinical experience with teduglutide in patients with SBS weighing less than 10 kg in Japan to clarify their background characteristics and clinical course. Specifically, the objective is to investigate patient background characteristics; growth and developmental status; changes in PS volume and the effect of these changes on long-term (beyond one year) prognosis; changes in nutritional status; effects on liver function and PS catheter management; caregiver burden at home; and improvements in QoL. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - - Legal guardian has signed and dated a written informed consent form - Corrected gestational age was 4 months or older at the start of teduglutide treatment - Body weight was less than 10 kg on the start date of teduglutide treatment - Diagnosis of SBS with intestinal failure, defined as dependence on PS to provide at least 30% of fluid or caloric requirements - The volumes of PS were stable following the intestinal adaptation period or further reduction was considered unlikely at the start of teduglutide treatment - Received at least one dose of teduglutide - Treatment with teduglutide was consistent with the approved indication Key exclusion criteria - - Legal guardian did not provide written informed consent - Use of teduglutide was determined to be off-label based on product information, as judged by the study doctor - The patient was known to have died at the time informed consent was obtained Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 18 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070204

Disclaimer: Curated by HT Syndication.