Pediatric Teduglutide Registry: Clinical Use of Teduglutide in Children With Intestinal Failure, a Multicenter Post-marketing Evaluation

P00033923

Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.

2021-05-18

2023-08-31

2023-08-31

Completed

142

Cohort A: Inclusion Criteria: 1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days 2. Received teduglutide after FDA approval 3. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation 4. Weight ≥ 10 kg at start of teduglutide initiation 5. Dependent on PS at the time of teduglutide initiation 6. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit. 7. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: 1. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304). 2. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance. Cohort B: Inclusion Criteria: 1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days 2. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304) 3. Currently receiving teduglutide 4. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: 1. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 142, 'type': 'ACTUAL'}}

2023-12-11