Status:
COMPLETED
Pediatric Teduglutide Registry
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Takeda
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
1+ years
Brief Summary
Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.
Detailed Description
This will be a multi-center post-marketing pediatric registry study evaluating the efficacy and safety of teduglutide. This is an observational longitudinal registry of pediatric SBS patients who are ...
Eligibility Criteria
Inclusion
- Cohort A:
- 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.
Exclusion
- 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.
- Cohort B:
- Inclusion Criteria:
- 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.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04832087
Start Date
May 18 2021
End Date
August 31 2023
Last Update
December 11 2023
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115