A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Teduglutide 0.05 milligram per kilogram (mg/kg) Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily. |
Drug: Teduglutide
Teduglutide 0.05 mg/kg SC injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Adverse Events [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 [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.
Secondary Outcome Measures
- Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support [Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation]
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.
- Percent Change from Baseline in Prescription Volume of PN/IV Support [Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation]
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).
- Changes from Baseline in Dose of PN/IV Support [Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation]
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.
- Percent Change from Baseline of Dose in PN/IV Support [Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation]
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).
- Percentage of Participants who Completely Wean off PN/IV Support [Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation]
Number of participants who completely wean off PN/IV support will be assessed.
- Crohn's Disease Activity Index (CDAI) [36 months after teduglutide treatment initiation]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Takeda Selected Site | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-633-5001