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
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