CompletedNot Applicable

Pediatric Teduglutide Registry

United States142 participantsStarted 2021-05-18

Plain-language summary

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

Age range1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
✓. Received teduglutide after FDA approval
✓. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation
✓. Weight ≥ 10 kg at start of teduglutide initiation
✓. Dependent on PS at the time of teduglutide initiation
✓. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit.
✓. 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.

✕. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304).
✕. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.
✕. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
✕. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304)
✕. Currently receiving teduglutide
✕. 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.

Percent change in calories from parenteral support (PS) (Kcal/kg/day)

Timeframe: Up to 3 years

NCT IDNCT04832087

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-31

Who can participate

Age range1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
✓. Received teduglutide after FDA approval
✓. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation
✓. Weight ≥ 10 kg at start of teduglutide initiation
✓. Dependent on PS at the time of teduglutide initiation
✓. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit.
✓. 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.

✕. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304).
✕. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.
✕. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
✕. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304)
✕. Currently receiving teduglutide
✕. 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.