Trial · NCT02949362
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
NCT02949362, Phase 3, Completed, Shire; results first posted 2021-06-14
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ConductScience Library. Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study. Trials, record NCT02949362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02949362
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
- NCT number
- NCT02949362
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 29 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, SOC
- First posted
- 2016-10-31
- Last updated
- 2025-03-19
- Other registries' IDs
- eudract:2016-000863-17
- Results first posted
- 2021-06-14
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | 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. |
| Primary | Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period | 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. |
| Primary | Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period | 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. |
| Primary | Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period | 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. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period | 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. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period | 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. |
| Primary | Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period | 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. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168) | Retrospective participants (RETRO): all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period | Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168) | 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. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period | Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168) | 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. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period | Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168) | 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. | Z-score | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period | From the beginning of the prospective study period to End of Study (EOS) (up to Week 144) | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12 | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 prospective TED/NTT group. | Z-score | MEAN |
| PRIMARY | 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 | Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24 | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 prospective TED/NTT group. | Z-score | MEAN |
| PRIMARY | 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 | Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12 | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 prospective TED/NTT group. | Z-score | MEAN |
| PRIMARY | Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period | Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12 | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 prospective TED/NTT group. | mL/kg/day | MEAN |
| PRIMARY | Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period | Baseline (from the beginning of the prospective study period) up to Week 108 | Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 prospective TED/TED group. | mL/kg/day | MEAN |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group368
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/NTT Group | Participants with AEs | 23 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/TED Group | Participants with AEs | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/NTT Group | Participants with Related AEs | 23 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/TED Group | Participants with Related AEs | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/NTT Group | Participants with SAEs | 23 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/TED Group | Participants with SAEs | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/NTT Group | Participants with Related SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) in Retrospective Observation Period | Retrospective TED/TED Group | Participants with Related SAE | 0 | Participants | |
| Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period | Retrospective TED/NTT Group | 0.128 | Standard Deviation 0.0505 | Z-score | |
| Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period | Retrospective TED/NTT Group | -0.181 | Standard Deviation 0.0601 | Z-score |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Retrospective Period | STARTED | Retrospective TED/NTT Group | 24 | |
| Retrospective Period | STARTED | Retrospective TED/TED Group | 5 | |
| Retrospective Period | STARTED | Prospective TED/NTT Group | 0 | |
| Retrospective Period | STARTED | Prospective TED/TED Group | 0 | |
| Retrospective Period | COMPLETED | Retrospective TED/NTT Group | 20 | |
| Retrospective Period | COMPLETED | Retrospective TED/TED Group | 4 | |
| Retrospective Period | COMPLETED | Prospective TED/NTT Group | 0 | |
| Retrospective Period | COMPLETED | Prospective TED/TED Group | 0 | |
| Retrospective Period | NOT COMPLETED | Retrospective TED/NTT Group | 4 | |
| Retrospective Period | NOT COMPLETED | Retrospective TED/TED Group | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events924
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Retrospective TED/NTT Group | 0 | 24 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Retrospective TED/TED Group | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Prospective TED/NTT Group | 1 | 5 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Prospective TED/TED Group | 3 | 19 | 7 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Retrospective TED/NTT Group | 0 | 24 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Retrospective TED/TED Group | 0 | 5 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Prospective TED/NTT Group | 0 | 5 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Prospective TED/TED Group | 1 | 19 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Retrospective TED/NTT Group | 0 | 24 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Retrospective TED/TED Group | 0 | 5 | 0 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Retrospective TED/NTT Group | 0 | 24 |
| Total, all-cause mortality | Retrospective TED/TED Group | 0 | 5 |
| Total, all-cause mortality | Prospective TED/NTT Group | 0 | 5 |
| Total, all-cause mortality | Prospective TED/TED Group | 0 | 19 |
| Total, other adverse events | Retrospective TED/NTT Group | 1 | 24 |
| Total, other adverse events | Retrospective TED/TED Group | 1 | 5 |
| Total, other adverse events | Prospective TED/NTT Group | 4 | 5 |
| Total, other adverse events | Prospective TED/TED Group | 18 | 19 |
| Total, serious adverse events | Retrospective TED/NTT Group | 23 | 24 |
| Total, serious adverse events | Retrospective TED/TED Group | 4 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02949362/registered?page=2