DRUG
Teduglutide
Standard of care Teduglutide dosing
Status
Completed
Phase
Not applicable
Enrollment
142
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.
Full 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 using FDA approved teduglutide as per standard of care.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 5, 2021
Study start
May 18, 2021
Primary completion
Aug 31, 2023
Study completion
Aug 31, 2023
Results posted
Not reported
Registry updated
Dec 11, 2023
Outcomes
What the study measures.
Primary outcomes
Percent change in calories from parenteral support (PS) (Kcal/kg/day)
Time frame · Up to 3 years
Maximum percent change in calories (energy intake in kcal/kg/day) from parenteral support relative to pre- treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.
Secondary outcomes
Percent change of (PS) volume (liters/week)
Time frame · Up to 3 years
Percent change of PS volume (liters/week) relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A
Percent change of PS infusions (number of days/week )
Time frame · Up to 3 years
Percent change of PS infusions (number of days/week relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A
Proportion of subjects completely weaned from PS
Time frame · Up to 3 years
Number (proportion) of children who wean completely from PS within 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.
Adverse Events
Time frame · Up to 3 years
Number (proportion) of subjects with adverse events among Cohort A. Number (proportion) of subjects with adverse events among Cohort B.
Weight-for-age Z-score (WAZ)
Time frame · Up to 3 years
Mean change in Weight-for-age Z-score (WAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.
Height-for-age-Z-score (HAZ)
Time frame · Up to 3 years
Mean change in Height-for-age-Z-score (HAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.
Body-Mass-Index Z-score (BMIZ)
Time frame · Up to 3 years
Mean change in Body-Mass-Index Z-score (BMIZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.
Eligibility
Who can take part.
- Minimum age
- 1 Year
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Boston Children's Hospital
Boston, Massachusetts, United States
Publications
Results and literature.
PMID 31495952 ↗Kocoshis SA, Merritt RJ, Hill S, Protheroe S, Carter BA, Horslen S, Hu S, Kaufman SS, Mercer DF, Pakarinen MP, Venick RS, Wales PW, Grimm AA. Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr. 2020 May;44(4):621-631. doi: 10.1002/jpen.1690. Epub 2019 Sep 8.PMID 27855998 ↗Carter BA, Cohran VC, Cole CR, Corkins MR, Dimmitt RA, Duggan C, Hill S, Horslen S, Lim JD, Mercer DF, Merritt RJ, Nichol PF, Sigurdsson L, Teitelbaum DH, Thompson J, Vanderpool C, Vaughan JF, Li B, Youssef NN, Venick RS, Kocoshis SA. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. J Pediatr. 2017 Feb;181:102-111.e5. doi: 10.1016/j.jpeds.2016.10.027. Epub 2016 Nov 15.
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