Trial · NCT03596164
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
NCT03596164, Phase 3, Completed, Takeda; results first posted 2023-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004. Trials, record NCT03596164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03596164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
- NCT number
- NCT03596164
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 11 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, Syringe, Needle, Vial Adapter for Device
- First posted
- 2018-07-23
- Last updated
- 2023-03-15
- Results first posted
- 2023-03-15
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Percent Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | |
| Primary | Change From Baseline in Days Per Week of PS | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Change From Baseline in Plasma Citrulline Levels | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | liter per week (L/Week) | MEAN |
| PRIMARY | Percent Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | percent change | MEAN |
| PRIMARY | Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Days Per Week of PS | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | days per week | MEAN |
| PRIMARY | Change From Baseline in Plasma Citrulline Levels | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | micromoles per liter | MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The safety population included all enrolled participants in the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
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 Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | SHP633-306: Teduglutide 0.05 mg/kg | 3 | Participants | ||
| Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | TED-C14-004: Teduglutide 0.05 mg/kg | 5 | Participants | ||
| Change From Baseline in Weekly PS Volume | SHP633-306: Teduglutide 0.05 mg/kg | -7.45 | Standard Deviation 7.908 | liter per week (L/Week) | |
| Change From Baseline in Weekly PS Volume | TED-C14-004: Teduglutide 0.05 mg/kg | -8.67 | Standard Deviation 7.450 | liter per week (L/Week) | |
| Percent Change From Baseline in Weekly PS Volume | SHP633-306: Teduglutide 0.05 mg/kg | -49.55 | Standard Deviation 41.411 | percent change | |
| Percent Change From Baseline in Weekly PS Volume | TED-C14-004: Teduglutide 0.05 mg/kg | -52.52 | Standard Deviation 39.828 | percent change | |
| Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | SHP633-306: Teduglutide 0.05 mg/kg | 1 | Participants | ||
| Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | TED-C14-004: Teduglutide 0.05 mg/kg | 2 | Participants | ||
| Change From Baseline in Days Per Week of PS | SHP633-306: Teduglutide 0.05 mg/kg | -2.3 | Standard Deviation 3.30 | days per week | |
| Change From Baseline in Days Per Week of PS | TED-C14-004: Teduglutide 0.05 mg/kg | -2.0 | Standard Deviation 3.42 | days per week |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP633-306: Teduglutide 0.05 mg/kg | 4 | |
| Overall Study | STARTED | TED-C14-004: Teduglutide 0.05 mg/kg | 7 | |
| Overall Study | COMPLETED | SHP633-306: Teduglutide 0.05 mg/kg | 3 | |
| Overall Study | COMPLETED | TED-C14-004: Teduglutide 0.05 mg/kg | 6 | |
| Overall Study | NOT COMPLETED | SHP633-306: Teduglutide 0.05 mg/kg | 1 | |
| Overall Study | NOT COMPLETED | TED-C14-004: Teduglutide 0.05 mg/kg | 1 |
Source ClinicalTrials.gov
Adverse events222
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 | Abdominal discomfort | Gastrointestinal disorders | SHP633-306: Teduglutide 0.05 mg/kg | 0 | 4 | |
| other | Abdominal discomfort | Gastrointestinal disorders | TED-C14-004: Teduglutide 0.05 mg/kg | 1 | 7 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Total Participants | 1 | 11 | |
| other | Abdominal distension | Gastrointestinal disorders | SHP633-306: Teduglutide 0.05 mg/kg | 1 | 4 | |
| other | Abdominal distension | Gastrointestinal disorders | TED-C14-004: Teduglutide 0.05 mg/kg | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Total Participants | 1 | 11 | |
| other | Abdominal pain | Gastrointestinal disorders | SHP633-306: Teduglutide 0.05 mg/kg | 0 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | TED-C14-004: Teduglutide 0.05 mg/kg | 1 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Total Participants | 1 | 11 | |
| other | Anal abscess | Infections and infestations | SHP633-306: Teduglutide 0.05 mg/kg | 1 | 4 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP633-306: Teduglutide 0.05 mg/kg | 1 | 4 |
| Total, all-cause mortality | TED-C14-004: Teduglutide 0.05 mg/kg | 0 | 7 |
| Total, all-cause mortality | Total Participants | 1 | 11 |
| Total, other adverse events | SHP633-306: Teduglutide 0.05 mg/kg | 4 | 4 |
| Total, other adverse events | TED-C14-004: Teduglutide 0.05 mg/kg | 7 | 7 |
| Total, other adverse events | Total Participants | 11 | 11 |
| Total, serious adverse events | SHP633-306: Teduglutide 0.05 mg/kg | 3 | 4 |
| Total, serious adverse events | TED-C14-004: Teduglutide 0.05 mg/kg | 4 | 7 |
| Total, serious adverse events | Total Participants | 7 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg vs TED-C14-004: Teduglutide 0.05 mg/kg: Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | Trial comparisons |
SHP633-306: Teduglutide 0.05 mg/kg vs TED-C14-004: Teduglutide 0.05 mg/kg: Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | 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.
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GET https://conductscience.org/api/trials/v1/NCT03596164/results?page=2