Short Bowel Syndrome
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Growth-related parameter (weight-for-age Z-score) from the start date of teduglutide treatment through Week 52 - Background characteristics of pediatric patients with SBS weighing less than 10 kg who received teduglutide | — |
Secondary
| Measure | Time frame |
|---|---|
| - Growth-related parameters (height, weight, and head circumference-for-age Z-scores) after teduglutide treatment - PS volume and frequency after teduglutide treatment - Evaluation of PS volume reduction after teduglutide treatment - Parameters related to weaning from PS - Parameters related to changes in intestinal absorption capacity after teduglutide treatment | — |
Countries
Japan
Contacts
Public ContactMayu Suzuki
Takeda Pharmaceutical Company Limited Japan Medical Office
Outcome results
None listed