Clinical trial NCT04883606: A Study With Teduglutide (Revestive®) in Adults With Short Bowl Syndrome
Official title: Non-interventional, Multicenter Retrospective Study of the Effectiveness and Safety of Teduglutide (Revestive®) in Short Bowel Syndrome Adult Patients in Spain (T-Rex Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SBS-IF participants with age greater than equal to (\>=) 18 years treated with teduglutide in Spain.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1
timeFrame: Month 1
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 2
timeFrame: Month 2
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 3
timeFrame: Month 3
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 9
timeFrame: Month 9
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 12
timeFrame: Month 12
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 18
timeFrame: Month 18
measure: Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 24
timeFrame: Month 24
Secondary outcomes:
measure: Average Change in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Requirement
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Time to Achieve Response up to Month 24
timeFrame: Baseline up to Month 24
measure: Average Change in PN/IV Caloric Intake
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Average Change in Number of Days per Week With PN/IV Usage
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Number of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Number of Participants With Independence From PN and IV Fluid Support
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Median Time to Achieve any Response After Teduglutide Treatment Initiation.
timeFrame: Up to Month 24
measure: Median Time to Achieve Independence From PN and IV Fluid Support
timeFrame: Up to Month 24
measure: Average Change in Body Mass Index (BMI)
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Average Change in Daily Urine Volume
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation
measure: Average Change in Stool Characteristics
timeFrame: 6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation
measure: Average Change in Daily Fluids Intake
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Average Change in Daily Calories Oral Intake
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Average Change in Blood Parameters Such as Serum Albumin and Serum Pre-albumin
timeFrame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Month 6 after teduglutide treatment discontinuation
measure: Number of Participants who Discontinued Treatment due to any Cause
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: