Trial · NCT03571516
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
NCT03571516, Phase 3, Completed, Shire; results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome. Trials, record NCT03571516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03571516
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
- NCT number
- NCT03571516
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, Standard Medical Therapy, Syringe, Needle
- First posted
- 2018-06-27
- Last updated
- 2021-05-11
- Other registries' IDs
- eudract:2017-003606-40
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 24) | Number of participants who achieved at least 20% reduction from baseline in weight-normalized PS volume at EOT/ET (up to Week 24) were reported. EOT/ET was defined as the last available visit after the date of first dose (or randomization in standard of care treatment group) during the 24-week treatment period. |
| Secondary | Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Baseline: Pre-dose,1, 4 hours post-dose, and 2 hours post-dose at Week 7 | Mean plasma concentration of teduglutide was reported. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study treatment up to end of study (EOS) (up to Week 28) | An adverse event (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. TEAEs are defined as AEs that start or deteriorate on or after the date of the first dose of investigational product. |
| Secondary | Change From Baseline in Body Weight Z-score at Week 24 | Baseline, Week 24 | Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. 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 Z-score at Week 24 was reported. |
| Secondary | Change From Baseline in Length Z-Score at Week 24 | Baseline, Week 24 | Length was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. 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 length Z-score at Week 24 was reported. |
| Secondary | Change From Baseline in Head Circumference Z-Score at Week 24 | Baseline, Week 24 | Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. 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 head circumference Z-score at Week 24 was reported. |
| Secondary | Change From Baseline in Weight-for-Length Z-Score at Week 24 | Baseline, Week 24 | Weight-for-length was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population)/standard deviation value of reference population. 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 weight-for-length Z-score at Week 24 was reported. |
| Secondary | Change From Baseline in Average Total Urine Output at Week 24 | Baseline, Week 24 | Average total urine output was recorded over a 48-hour period of nutritional stability at Week 24 was reported. Here, milliliter per kilogram per day is abbreviated as mL/kg/day. |
| Secondary | Change From Baseline in Fecal Output at Week 24 | Baseline, Week 24 | Change from baseline in the fecal output (average number of stools per day) at Week 24 was reported. |
| Secondary | Number of Participants With Positive Specific Antibodies to Teduglutide | Baseline, EOS (up to week 28) | Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 24) | Intent-to-Treat (ITT) set consisted of all participants randomized in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Baseline: Pre-dose,1, 4 hours post-dose, and 2 hours post-dose at Week 7 | Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of teduglutide and had at least 1 evaluable and interpretable post-dose PK concentration value. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data was not planned to be collected and analyzed for SOC arm. | Nanogram per milliliter (ng/mL) | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study treatment up to end of study (EOS) (up to Week 28) | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Body Weight Z-score at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Z-score | MEAN |
| SECONDARY | Change From Baseline in Length Z-Score at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Z-Score | MEAN |
| SECONDARY | Change From Baseline in Head Circumference Z-Score at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Z-Score | MEAN |
| SECONDARY | Change From Baseline in Weight-for-Length Z-Score at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Z-Score | MEAN |
| SECONDARY | Change From Baseline in Average Total Urine Output at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | mL/kg/day | MEAN |
| SECONDARY | Change From Baseline in Fecal Output at Week 24 | Baseline, Week 24 | Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Average number of stools per day | MEAN |
| SECONDARY | Number of Participants With Positive Specific Antibodies to Teduglutide | Baseline, EOS (up to week 28) | Safety set: all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data for this outcome was not planned to be collected and analyzed for SOC group. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Teduglutide (TED) | Diary Data: EOT/ET | 3 | Participants | |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Standard of Care (SOC) | Diary Data: EOT/ET | 1 | Participants | |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Teduglutide (TED) | Prescribed Data: EOT/ET | 3 | Participants | |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Standard of Care (SOC) | Prescribed Data: EOT/ET | 3 | Participants | |
| Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Teduglutide (TED) | Baseline: At Pre-dose | 0.00 | Full Range 0.00 to 0.00 | Nanogram per milliliter (ng/mL) |
| Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Teduglutide (TED) | Baseline: At 1 hour | 16.300 | Full Range 7.25 to 25.70 | Nanogram per milliliter (ng/mL) |
| Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Teduglutide (TED) | Baseline: At 4 hours | 8.385 | Full Range 3.86 to 22.5 | Nanogram per milliliter (ng/mL) |
| Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7) | Teduglutide (TED) | Week 7: At 2 hours | 16.950 | Full Range 14.80 to 19.10 | Nanogram per milliliter (ng/mL) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Teduglutide (TED) | 5 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Standard of Care (SOC) | 5 | Participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teduglutide (TED) | 5 | |
| Overall Study | STARTED | Standard of Care (SOC) | 5 | |
| Overall Study | COMPLETED | Teduglutide (TED) | 4 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 4 | |
| Overall Study | NOT COMPLETED | Teduglutide (TED) | 1 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) | 1 |
Source ClinicalTrials.gov
Adverse events110
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 | Teduglutide (TED) | 1 | 5 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 0 | 5 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Teduglutide (TED) | 1 | 5 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Teduglutide (TED) | 1 | 5 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Standard of Care (SOC) | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Teduglutide (TED) | 1 | 5 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Standard of Care (SOC) | 0 | 5 | 0 |
| other | Abnormal faeces | Gastrointestinal disorders | Teduglutide (TED) | 1 | 5 | 1 |
| other | Abnormal faeces | Gastrointestinal disorders | Standard of Care (SOC) | 0 | 5 | 0 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teduglutide (TED) | 0 | 5 |
| Total, all-cause mortality | Standard of Care (SOC) | 0 | 5 |
| Total, other adverse events | Teduglutide (TED) | 5 | 5 |
| Total, other adverse events | Standard of Care (SOC) | 5 | 5 |
| Total, serious adverse events | Teduglutide (TED) | 4 | 5 |
| Total, serious adverse events | Standard of Care (SOC) | 3 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37364133 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Teduglutide (TED) vs Standard of Care (SOC): Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning Off (Enteral Autonomy) Parenteral Support (PS) Volume at Week 24 | Trial comparisons |
Teduglutide (TED) vs Standard of Care (SOC): Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning Off (Enteral Autonomy) Parenteral Support (PS) Volume at End of Study (EOS) | Trial comparisons |
| Teduglutide (TED) vs Standard of Care (SOC): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Teduglutide (TED) vs Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Teduglutide (TED) vs Standard of Care (SOC): serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03571516
GET https://conductscience.org/api/trials/v1/NCT03571516/registered?page=2