FindTrial
Sign In

A Study With Teduglutide (Revestive®) in Adults With Short Bowl Syndrome

Non-interventional, Multicenter Retrospective Study of the Effectiveness and Safety of Teduglutide (Revestive®) in Short Bowel Syndrome Adult Patients in Spain (T-Rex Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04883606
Acronym
T-Rex
Enrollment
65
Registered
2021-05-12
Start date
2022-01-26
Completion date
2023-07-24
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Brief 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

None listed

Sponsors

Takeda
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1Month 1Percentage 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 2Month 2Percentage 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 3Month 3Percentage 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 6Month 6Percentage 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 9Month 9Percentage 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 12Month 12Percentage 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 18Month 18Percentage 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 24Month 24Percentage 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.

Secondary

MeasureTime frameDescription
Average Change in Body Mass Index (BMI)6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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 Volume6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiationAverage 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.
Average Change in Stool Characteristics6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiationAverage change in stool characteristics from 6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation will be assessed.
Average Change in Daily Fluids Intake6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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.
Average Change in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Requirement6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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.
Average Change in Blood Parameters Such as Serum Albumin and Serum Pre-albumin6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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.
Number of Participants With Adverse Events (AEs)Up to Month 6 after teduglutide treatment discontinuationAn 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.
Number of Participants who Discontinued Treatment due to any CauseUp to Month 24Number of participants who discontinued treatment due to any cause (treatment discontinuation, worsening health conditions, withdrawal of consent) will be reported.
Average Change in Daily Calories Oral Intake6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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.
Time to Achieve Response up to Month 24Baseline up to Month 24Response 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 Intake6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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 Usage6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationAverage 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 Volume6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationNumber 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 Support6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiationNumber 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.Up to Month 24Median time to achieve any response after teduglutide treatment initiation will be assessed.
Median Time to Achieve Independence From PN and IV Fluid SupportUp to Month 24Median time to achieve independence on PN and IV fluid support after treatment with teduglutide will be assessed.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026