Status
Completed
Phase
Not applicable
Enrollment
65
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
No intervention details reported.
Timeline
First posted
May 12, 2021
Study start
Jan 26, 2022
Primary completion
Jul 24, 2023
Study completion
Jul 24, 2023
Results posted
Not reported
Registry updated
Aug 31, 2023
Outcomes
Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 2
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 3
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 6
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 9
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 12
Time frame · Month 12
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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 18
Time frame · 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.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 24
Time frame · 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.
Average Change in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Requirement
Time frame · 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 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.
Time to Achieve Response up to Month 24
Time frame · Baseline 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.
Average Change in PN/IV Caloric Intake
Time frame · 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 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.
Average Change in Number of Days per Week With PN/IV Usage
Time frame · 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 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.
Number of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume
Time frame · 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 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.
Number of Participants With Independence From PN and IV Fluid Support
Time frame · 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 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.
Median Time to Achieve any Response After Teduglutide Treatment Initiation.
Time frame · Up to Month 24
Median time to achieve any response after teduglutide treatment initiation will be assessed.
Median Time to Achieve Independence From PN and IV Fluid Support
Time frame · Up to Month 24
Median time to achieve independence on PN and IV fluid support after treatment with teduglutide will be assessed.
Average Change in Body Mass Index (BMI)
Time frame · 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 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.
Average Change in Daily Urine Volume
Time frame · 6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation
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.
Eligibility
Inclusion Criteria: * Participants \>= 18 years of age diagnosed with intestinal failure due to SBS as a result of intestinal resection. * SBS-IF participants treated with teduglutide according to Summary of Product Characteristics (SmPC). * Patients who receive or have received teduglutide for at least six months at the date of inclusion (from treatment initiation to inclusion date, date of discontinuation, death for any cause or loss of follow-up). * When required by the ethics committee of the center: participants who have signed the informed consent form (ICF) to participate in the study. Exclusion Criteria: \- Participants who do not meet the inclusion criteria.
Study locations
Spain. Showing up to 24 locations stored in the fast local snapshot.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Publications
No PMID-linked publications were present in this registry snapshot.
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