Trial · NCT05027308
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
NCT05027308, Phase 3, Completed, Takeda; results first posted 2024-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older. Trials, record NCT05027308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05027308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
- NCT number
- NCT05027308
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide
- First posted
- 2021-08-30
- Last updated
- 2024-05-16
- Other registries' IDs
- eudract:2022-003572-16
- Results first posted
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until follow-up visit (4 weeks after end of treatment [EOT]/end of termination [ET] {up to 47.3-51.3 weeks}) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event. |
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AESI, whether serious or non-serious, is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Vital signs include systolic and diastolic blood pressure, heart rate and body temperature. |
| Primary | Change From Baseline in Body Weight Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for age Z-score below -2 indicates underweight. |
| Primary | Change From Baseline in Height Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a height for age Z-score below -2 indicates stunted. |
| Primary | Change From Baseline in Head Circumference Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to the Food and Nutrition Technical Assistance (FANTA) Guide to Anthropometry used for assessment of this outcome measure, a head circumference for age Z-score below -2 indicates small head circumference. |
| Primary | Change From Baseline in Weight-for-Length Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for length Z-score below -2 indicates wasted (recent and severe weight loss). |
| Primary | Number of Participants With Any Laboratory Safety Finding Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Laboratory safety parameters included biochemistry, hematology, and urinalysis. |
| Primary | Number of Participants With a Change in Urine Output Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Urine and stool output was recorded and calculated in the output diary over a 48-hour period of parenteral support (PS) and enteral nutrition (EN) stability before every site visit and within 1 week of implementing a change in the PS prescription. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until follow-up visit (4 weeks after end of treatment [EOT]/end of termination [ET] {up to 47.3-51.3 weeks}) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESIs) | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Body Weight Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Z score | MEAN |
| PRIMARY | Change From Baseline in Height Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Z score | MEAN |
| PRIMARY | Change From Baseline in Head Circumference Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. Overall number analyzed is the number of participants with data available for analyses. | Z score | MEAN |
| PRIMARY | Change From Baseline in Weight-for-Length Z-Score at EOT | Baseline, EOT (up to 47.3-51.3 weeks) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. Overall number analyzed is the number of participants with data available for analyses. | Z score | MEAN |
| PRIMARY | Number of Participants With Any Laboratory Safety Finding Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Change in Urine Output Reported as an Adverse Event | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group131
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 Treatment-emergent Adverse Events (TEAEs) | Teduglutide | 3 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Teduglutide | 3 | Participants | ||
| Number of Participants With Adverse Events of Special Interest (AESIs) | Teduglutide | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event | Teduglutide | 0 | Participants | ||
| Change From Baseline in Body Weight Z-Score at EOT | Teduglutide | 1.637 | Standard Deviation 2.8839 | Z score | |
| Change From Baseline in Height Z-Score at EOT | Teduglutide | 0.590 | Standard Deviation 1.9949 | Z score | |
| Change From Baseline in Head Circumference Z-Score at EOT | Teduglutide | 1.130 | Standard Deviation 0.4101 | Z score | |
| Change From Baseline in Weight-for-Length Z-Score at EOT | Teduglutide | 4.240 | Standard Deviation NA | Z score | |
| Number of Participants With Any Laboratory Safety Finding Reported as an Adverse Event | Teduglutide | 1 | Participants | ||
| Number of Participants With a Change in Urine Output Reported as an Adverse Event | Teduglutide | 1 | Participants |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teduglutide | 3 | |
| Overall Study | COMPLETED | Teduglutide | 3 | |
| Overall Study | NOT COMPLETED | Teduglutide | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Blood iron increased | Investigations | Teduglutide | 1 | 3 | |
| other | COVID-19 | Infections and infestations | Teduglutide | 2 | 3 | |
| other | Catheter site rash | General disorders | Teduglutide | 1 | 3 | |
| other | Enterocolitis | Gastrointestinal disorders | Teduglutide | 2 | 3 | |
| other | Lactic acidosis | Metabolism and nutrition disorders | Teduglutide | 1 | 3 | |
| other | Liver disorder | Hepatobiliary disorders | Teduglutide | 1 | 3 | |
| other | Oliguria | Renal and urinary disorders | Teduglutide | 1 | 3 | |
| other | Parainfluenzae virus infection | Infections and infestations | Teduglutide | 1 | 3 | |
| other | Respiratory syncytial virus infection | Infections and infestations | Teduglutide | 2 | 3 | |
| other | Skin candida | Infections and infestations | Teduglutide | 1 | 3 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teduglutide | 0 | 3 |
| Total, other adverse events | Teduglutide | 3 | 3 |
| Total, serious adverse events | Teduglutide | 3 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41454663 | 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 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.
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/NCT05027308
GET https://conductscience.org/api/trials/v1/NCT05027308/results?page=2