This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.
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See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to follow-up (up to 46 months)
Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Number of Participants With Positive Specific Antibodies at End of Study (EOS)
Timeframe: At EOS (up to 46 months)
Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)
Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment
Timeframe: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Timeframe: Baseline, Last visit in NT (up to Month 39)