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Report for D012778: Short Bowel Syndrome NIH
(Synonyms: Short Bowel Syndrome)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (0)
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Correlated HPO Terms (0)
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There is one clinical trial.
Clinical Trials
1 A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.
NCT01990040 Short Bowel Syndrome MeSH:Short Bowel Syndrome Syndrome
Primary Outcomes
Description: Incidence rates of colorectal cancer in participants will be calculated by dividing the number of incident colorectal cancer cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide Time: 10 yearsSecondary Outcomes
Description: Incidence rates of other malignancies will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Other Malignancy Time: 10 yearsDescription: Incidence rates of benign neoplasia of the GI tract, hepatobiliary system, and pancreas will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants Time: 10 yearsDescription: Incidence rates of colorectal polyps will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Colorectal Polyps Time: 10 yearsDescription: Incidence rates of intestinal obstruction will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Intestinal Obstruction Time: 10 yearsDescription: Incidence rates of pancreatic and biliary disease will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Pancreatic and Biliary Disease Time: 10 yearsDescription: Incidence rates of heart failure and other manifestations of volume overload will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Heart Failure and Other Manifestations of Volume Overload Time: 10 yearsDescription: Incidence rates of allergic/hypersensitivity reactions to teduglutide will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.
Measure: Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide Time: 10 yearsDescription: Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE 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 (ICH Guidance E2A 1995). This includes an exacerbation of a pre-existing condition.
Measure: Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide Time: 10 yearsDescription: PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Measure: Actual Volume Change in Parenteral Support (PS) Time: 10 yearsDescription: PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Measure: Percentage Volume Change in Parenteral Support (PS) Time: 10 yearsDescription: PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Measure: Actual Change in the Number of Days per Week on Parenteral Support (PS) Time: 10 yearsDescription: PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Measure: Percentage Change in the Number of Days per Week on Parenteral Support (PS) Time: 10 yearsDescription: PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Measure: Percent of Participants Weaning From Parental Support (PS) Time: 10 years