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| ID | Type | Description | Link |
|---|---|---|---|
| MACS-2020-04220 | Other Identifier | Takeda |
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The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®).
This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected during this study. Only data already available in the hospital records will be reviewed and collected for this study.
Participants do not need to visit their doctor in addition to their normal visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Retrospective data will be collected from participants who followed up at least 6 months before teduglutide initiation or intestinal failure associated with SBS-IF diagnosis and at least 6 months of follow-up after teduglutide treatment initiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 1 after teduglutide treatment initiation will be reported. | Month 1 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 2 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 2 after teduglutide treatment initiation will be reported. | Month 2 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 3 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 3 after teduglutide treatment initiation will be reported. | Month 3 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 6 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 6 after teduglutide treatment initiation will be reported. | Month 6 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 9 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 9 after teduglutide treatment initiation will be reported. | Month 9 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Requirement | Average change in weekly volume of PN/IV requirement since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
- Participants who do not meet the inclusion criteria.
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SBS-IF participants with age greater than equal to (>=) 18 years treated with teduglutide in Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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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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Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 12 after teduglutide treatment initiation will be reported. |
| Month 12 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 18 | Percentage of participants achieveing response of 20% to 100% reduction from baseline in weekly PS volume at Month 18 after teduglutide treatment initiation will be reported. | Month 18 |
| Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 24 | Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 24 after teduglutide treatment initiation will be reported. | Month 24 |
| Time to Achieve Response up to Month 24 | Response is defined as the achievement of a 20% to 100% reduction in weekly PS volume from baseline up to Month 24. | Baseline up to Month 24 |
| Average Change in PN/IV Caloric Intake | Average change in PN/IV calories intake since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Average Change in Number of Days per Week With PN/IV Usage | Average change in number of days per week with PN/IV since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Number of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume | Number of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume since 6 months before teduglutide treatment initiation to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be reported. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Number of Participants With Independence From PN and IV Fluid Support | Number of participants with independence from PN and IV fluid support since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Median Time to Achieve any Response After Teduglutide Treatment Initiation. | Median time to achieve any response after teduglutide treatment initiation will be assessed. | Up to Month 24 |
| Median Time to Achieve Independence From PN and IV Fluid Support | Median time to achieve independence on PN and IV fluid support after treatment with teduglutide will be assessed. | Up to Month 24 |
| Average Change in Body Mass Index (BMI) | Average change in BMI after treatment with teduglutide since 6 months before teduglutide treatment initiation up to 1, 2, 3, 6, 9, 12, 18 and 24 months after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Average Change in Daily Urine Volume | Average change in daily urine volume since 6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation |
| Average Change in Stool Characteristics | Average change in stool characteristics from 6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation |
| Average Change in Daily Fluids Intake | Average change in fluids daily intake since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Average Change in Daily Calories Oral Intake | Average change in daily calories oral intake since 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation will be assessed. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Average Change in Blood Parameters Such as Serum Albumin and Serum Pre-albumin | Average change in blood parameters such as serum albumin and serum pre-albumin will be analyzed at 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 12, 18 and 24 after teduglutide treatment initiation. | 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation |
| Number of Participants With Adverse Events (AEs) | An adverse event (AEs) 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 Serious adverse event (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. | Up to Month 6 after teduglutide treatment discontinuation |
| Number of Participants who Discontinued Treatment due to any Cause | Number of participants who discontinued treatment due to any cause (treatment discontinuation, worsening health conditions, withdrawal of consent) will be reported. | Up to Month 24 |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |