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| ID | Type | Description | Link |
|---|---|---|---|
| MACS-2020-112501 | Other Identifier | Takeda |
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The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada.
This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study.
The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With SBS-IF | Participants with SBS-IF who as part of standard or routine clinical practice, must have received teduglutide (Revestive®) treatment and were dependent on parenteral support prior to teduglutide treatment initiation will be observed in this retrospective observational study for up to 48 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional Study | Other | This is non-interventional study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24 | Weekly volume of PN/IV fluid requirement at baseline before teduglutide treatment and at Week 24 after initiation of teduglutide treatment will be reported. | Baseline and at Week 24 |
| Average Change in Number of Days per Week With PN/IV Usage | Average change in number of days per week with PN/IV usage in the 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation will be reported. | 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months |
| Percentage of Participants Achieving PN/IV Independence During the Study Period | Percentage of participants who will achieve PN/IV independence during the study period will be reported. | Up to 48 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Volume of PN/IV Fluid Requirement | Change from baseline in weekly volume of PN/IV fluid requirement at 6,12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported. | Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment |
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Inclusion criteria:
Exclusion criteria:
- Participants with active gastrointestinal malignancy OR a history of gastrointestinal malignancy in the past 5 years before start of treatment.
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Participants with SBS-IF, who were treated with teduglutide (Revestive®) in Canada will be observed in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innomar Strategies | Oakville | Ontario | L6L 0C4 | Canada |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume |
Number of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume will be reported. |
| Up to 48 months after teduglutide treatment initiation |
| Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume | Percentage of participants achieving 20% to 100% reduction from baseline in weekly PS volume at 6, 12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported. | Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment |
| Change From Baseline in Number of Days per Week With PN/IV Usage | Change from baseline in number of days per week with PN/IV usage at 6,12, 24, 36 and 48 months after teduglutide treatment initiation will be reported. | Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment |
| Number of Participants With Reasons of Treatment Interruption and Discontinuation | Number of participants with reasons of treatment interruption and discontinuation will be reported. | From teduglutide treatment initiation up to 48 months |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. | From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 48 months) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |