Short Bowel SyndromeNCT05023382
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
An observational study of Short Bowel Syndrome, run by Takeda at 1 site in Japan.
Trial summary
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Teduglutide
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2021to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
Who may be able to join
- All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.
- Conditions
- Short Bowel Syndrome
- Being tested
- Teduglutide
- 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
Also called TAK-633, Revestive
Teduglutide 0.05 mg/kg SC injection
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide 0.05 milligram per kilogram (mg/kg) | Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily. Receives: Drug: Teduglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 36 months
Number of Participants with Serious Adverse Events
A serious AE is any untoward medical occurrence or effect 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, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Up to 36 months
Secondary outcomes (6)
Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support
Changes from baseline in prescription volume of PN/IV support prescribed by investigators to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.
Measured: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline in Prescription Volume of PN/IV Support
Percent change from baseline in prescription volume of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [prescription volume at each timepoint - prescription volume at baseline] / prescription volume at baseline * 100 (percent).
Measured: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Changes from Baseline in Dose of PN/IV Support
Changes from baseline in actual dose of PN/IV support to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.
Measured: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline of Dose in PN/IV Support
Percent change from baseline in actual dose of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [actual dose at each timepoint - actual dose at baseline] / actual dose at baseline * 100 (percent).
Measured: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percentage of Participants who Completely Wean off PN/IV Support
Number of participants who completely wean off PN/IV support will be assessed.
Measured: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Crohn's Disease Activity Index (CDAI)
CDAI score is calculated from the following 8 items: (a) Number of liquid or very soft stools; (b) Abdominal pain; (c) General wellbeing; (d) Extraintestinal complications; (e) Antidiarrhoeal drugs; (f) Abdominal mass; (g) Hematocrit; and (h) Body weight. Scores of some items in CDAI are calculated based on patient diary. Total range of score is more than 0. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450.
Measured: 36 months after teduglutide treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023382
- Sponsor's protocol ID
- TAK-633-5001
- Other IDs
- jRCT2031210284
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Wada M, Nakamura S, Hayashi A, Otake R, Miyamoto M, Tanaka T. Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance. Adv Ther. 2026 Jan;43(1):425-441. doi: 10.1007/s12325-025-03398-y. Epub 2025 Dec 1.
PubMed 41324792
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
- ClinicalTrials.gov ID
- NCT05023382
- Acronym / sponsor ID
- TAK-633-5001
- Conditions
- Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teduglutide 0.05 milligram per kilogram (mg/kg) | – | Drug: TeduglutideParticipants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
Key inclusion criteria (1 listed)
- All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| TeduglutideAlso: TAK-633, RevestiveTeduglutide 0.05 mg/kg SC injection | Drug | Teduglutide 0.05 milligram per kilogram (mg/kg) |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to 36 months
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants with Serious Adverse Events
Time frame: Up to 36 months
A serious AE is any untoward medical occurrence or effect 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, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
6 secondary outcomes
Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support
Time frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline in Prescription Volume of PN/IV Support
Time frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Changes from Baseline in Dose of PN/IV Support
Time frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline of Dose in PN/IV Support
Time frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percentage of Participants who Completely Wean off PN/IV Support
Time frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Crohn's Disease Activity Index (CDAI)
Time frame: 36 months after teduglutide treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 41324792Wada M, Nakamura S, Hayashi A, Otake R, Miyamoto M, Tanaka T. Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance. Adv Ther. 2026 Jan;43(1):425-441. doi: 10.1007/s12325-025-03398-y. Epub 2025 Dec 1.
- Description: Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by Takeda at 1 site in Japan.
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 1 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Up to 36 months). The study lists 2 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 NCT05023382, which also lists 1 linked publication.
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 7 Aug 2026.