Short Bowel SyndromePhase 3NCT02949362

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

A Phase 3 study testing Teduglutide and SOC in people with Short Bowel Syndrome, run by Shire at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. Read more about this study

Who is it for?: Any age
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Teduglutide and SOC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 11 sitesin 2 countries
Study dates: 9 Dec 2016to 14 Jul 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures.
Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Who cannot join

There are no exclusion criteria for this study.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Childrens Hospital Los Angeles - RHU
Los Angeles, California, 90027
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
Seattle Children's Hospital
Seattle, Washington, 98105
Children's Hospital at Montefiore
The Bronx, New York, 10467

Other trials in United States

United Kingdom1 site

Great Ormond Children's Hospital
London, WC1N 3JH

Other trials in United Kingdom

About this study

Official title: A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003

Conditions: Short Bowel Syndrome
Being tested: Teduglutide, SOC
Medical subject headings: Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeduglutideDrug
0.05mg/kg
SOCOther
Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods

Study groups in NCT02949362
Study group	Role	What they receive
Standard of Care (SOC) Treatment +/- Teduglutide	Experimental	TED 0.05mg/kg subcutaneous injections once daily as needed in addition to SOC treatment Receives: Drug: Teduglutide; Other: SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) in Retrospective Observation Period
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Number of participants with AEs, related AEs, serious adverse events (SAEs) and related SAEs of retrospective observation period were reported.
Measured: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)
Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period
Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age greater than or equal to [>=] 2 years old) and World Health Organization (age less than [<] 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period
Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Week 168 was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period
BMI Z-score was calculated by using the retrospective height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period
TEAEs are defined as AEs that started or worsened on or after the first dose of teduglutide treatment in the core study. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. AESI was an TEAE or TESAE of scientific and medical concern specific to the sponsor's product or program and for which ongoing monitoring and immediate notification by the investigator to the sponsor. Number of participants With TEAEs, treatment -emergent serious adverse events (TESAEs) and adverse events of special interest (AESI) of Prospective study period were reported.
Measured: From the beginning of the prospective study period to End of Study (EOS) (up to Week 144)
Change From Baseline in Height for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
Change From Baseline in Body Weight for Age Z-score up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period
Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Cycle 6 Week 24 during the end of teduglutide treatment period of prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24
Change From Baseline in BMI for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in BMI for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported. Here, mL/kg/day is abbreviated as milliliter per kilogram per day.
Measured: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period
Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Week 108 during the end of NTT period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Week 108
Average Number of Stools Per Day up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period
Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to cycle 6 week 24 during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24
Average Number of Stools Per Day up to Week 120 During the End of NTT Period of Prospective Study Period
Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to Week 120 during the end of NTT period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period) up to Week 120
Number of Participants With Positive Specific Antibodies at EOS During the End of Teduglutide Treatment Period of Prospective Study Period
Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.
Measured: From the beginning of the prospective study period, EOS (up to Week 156)

Secondary outcomes (19)

Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Number of participants achieved at least 20% reduction in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported.
Measured: At Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Change from baseline in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Percent change from baseline in PS volume at 12 weeks interval up to Week 156 of retrospective observation period was reported.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Percent change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156
Percent Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study. Hence, percent change was not assessed in this study.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Percent change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported.
Measured: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Number of participants who achieved at least 20, 50 and 75% reduction in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: At EOT of each Cycles 1 to 6 (up to Week 140) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 20 weeks)
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Change from baseline in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Percent change from baseline in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Change from baseline in PS caloric intake at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Percent change from baseline in PS caloric intake at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: At EOT of each Cycles 1 to 6 (up to Week 144) (length of each Cycle 1 to 6 = 24 weeks)
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Percent change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Change from baseline in number of days per week of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Percent change from baseline in number of days per week of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.
Measured: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 201614 Jul 2020

First posted31 Oct 2016 (estimated)
Study start9 Dec 2016
Primary completion14 Jul 2020
Study completion14 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02949362
Sponsor's protocol ID: SHP633-303
Other IDs: 2016-000863-17, 2016
Status last verified: Mar 2025
First submitted: 5 Oct 2016
Last updated: 19 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.

Publications

Wendel D, Wales PW, Kocoshis S, Venick R, Carter B, Cohran V, Matthews C, Raphael BP, Robinson I, Hill S. Quality of life for pediatric patients with short bowel syndrome-associated intestinal failure treated with teduglutide. J Pediatr Gastroenterol Nutr. 2026 Jul;83(1):54-62. doi: 10.1002/jpn3.70358. Epub 2026 Mar 19.
PubMed 41858082
Wales PW, Hill S, Robinson I, Raphael BP, Matthews C, Cohran V, Carter B, Venick R, Kocoshis S. Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure. J Pediatr Gastroenterol Nutr. 2024 Aug;79(2):290-300. doi: 10.1002/jpn3.12276. Epub 2024 Jun 14.
PubMed 38873891

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
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Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
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All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003
ClinicalTrials.gov ID: NCT02949362
Acronym / sponsor ID: SHP633-303
Conditions: Short Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 9 Dec 2016 (actual)
Primary completion: 14 Jul 2020 (actual)
Study completion: 14 Jul 2020 (actual)
First posted: 31 Oct 2016 (estimated)
Results: Posted 14 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Standard of Care (SOC) Treatment +/- Teduglutide	Experimental	Drug: Teduglutide, Other: SOCTED 0.05mg/kg subcutaneous injections once daily as needed in addition to SOC treatment

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures.
Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Key exclusion criteria (1 listed)

There are no exclusion criteria for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Teduglutide0.05mg/kg	Drug	Standard of Care (SOC) Treatment +/- Teduglutide
SOCStandard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods	Other	Standard of Care (SOC) Treatment +/- Teduglutide

Primary outcome

Number of Participants With Adverse Events (AEs) in Retrospective Observation Period
Time frame: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Number of participants with AEs, related AEs, serious adverse events (SAEs) and related SAEs of retrospective observation period were reported.
Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age greater than or equal to [>=] 2 years old) and World Health Organization (age less than [<] 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Week 168 was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)
BMI Z-score was calculated by using the retrospective height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period
Time frame: From the beginning of the prospective study period to End of Study (EOS) (up to Week 144)
TEAEs are defined as AEs that started or worsened on or after the first dose of teduglutide treatment in the core study. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. AESI was an TEAE or TESAE of scientific and medical concern specific to the sponsor's product or program and for which ongoing monitoring and immediate notification by the investigator to the sponsor. Number of participants With TEAEs, treatment -emergent serious adverse events (TESAEs) and adverse events of special interest (AESI) of Prospective study period were reported.
Change From Baseline in Height for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment period in prospective study period was reported.
Change From Baseline in Body Weight for Age Z-score up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24
Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Cycle 6 Week 24 during the end of teduglutide treatment period of prospective study period was reported.
Change From Baseline in BMI for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in BMI for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported.
Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12
Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported. Here, mL/kg/day is abbreviated as milliliter per kilogram per day.
Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Week 108
Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Week 108 during the end of NTT period in prospective study period was reported.
Average Number of Stools Per Day up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24
Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to cycle 6 week 24 during the end of teduglutide treatment period in prospective study period was reported.
Average Number of Stools Per Day up to Week 120 During the End of NTT Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period) up to Week 120
Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to Week 120 during the end of NTT period in prospective study period was reported.
Number of Participants With Positive Specific Antibodies at EOS During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: From the beginning of the prospective study period, EOS (up to Week 156)
Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.

19 secondary outcomes

Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156
Percent Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period
Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: At EOT of each Cycles 1 to 6 (up to Week 140) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 20 weeks)
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: At EOT of each Cycles 1 to 6 (up to Week 144) (length of each Cycle 1 to 6 = 24 weeks)
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period
Time frame: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Results and safety

Results posted to the registry on 14 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retrospective TED/NTT Group	24	20
Retrospective TED/TED Group	5	4
Prospective TED/NTT Group	0	0
Prospective TED/TED Group	0	0

Primary outcome: Number of Participants With Adverse Events (AEs) in Retrospective Observation Period

Time frame: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168). Count of participants. Unit: Participants

Measure	Retrospective TED/NTT Group n = 24	Retrospective TED/TED Group n = 5
Participants with AEs	23	4
Participants with Related AEs	23	4
Participants with SAEs	23	4
Participants with Related SAE	0	0

Population analysed: Retrospective participants (RETRO): all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol.

Primary outcome: Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period

Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168). Mean (Standard Deviation). Unit: Z-score

Measure	Retrospective TED/NTT Group n = 2
Value	0.128 (0.0505)

Population analysed: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the retrospective TED/TED group.

Primary outcome: Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period

Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168). Mean (Standard Deviation). Unit: Z-score

Measure	Retrospective TED/NTT Group n = 2
Value	-0.181 (0.0601)

Primary outcome: Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period

Time frame: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168). Mean (Standard Deviation). Unit: Z-score

Measure	Retrospective TED/NTT Group n = 2
Value	-0.283 (0.0646)

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of screening up to end of the study (up to 168 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Retrospective TED/NTT Group	23 of 24 (95.8%)	1 of 24 (4.2%)	0 of 24
Retrospective TED/TED Group	4 of 5 (80%)	1 of 5 (20%)	0 of 5
Prospective TED/NTT Group	3 of 5 (60%)	4 of 5 (80%)	0 of 5
Prospective TED/TED Group	17 of 19 (89.5%)	18 of 19 (94.7%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41858082Wendel D, Wales PW, Kocoshis S, Venick R, Carter B, Cohran V, Matthews C, Raphael BP, Robinson I, Hill S. Quality of life for pediatric patients with short bowel syndrome-associated intestinal failure treated with teduglutide. J Pediatr Gastroenterol Nutr. 2026 Jul;83(1):54-62. doi: 10.1002/jpn3.70358. Epub 2026 Mar 19.
Derived from this study: PubMed 38873891Wales PW, Hill S, Robinson I, Raphael BP, Matthews C, Cohran V, Carter B, Venick R, Kocoshis S. Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure. J Pediatr Gastroenterol Nutr. 2024 Aug;79(2):290-300. doi: 10.1002/jpn3.12276. Epub 2024 Jun 14.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shire Study Physician principal investigator

Shire

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teduglutide and SOC in people with Short Bowel Syndrome, run by Shire at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) in Retrospective Observation Period (time frame: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02949362, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.