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

Short Bowel Syndrome Clinical Trial

— T-Rex  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883606
• Other study ID #: TAK-633-4002
• Secondary ID: MACS-2020-04220
• Status: Completed
• Start date: January 26, 2022
• Est. completion date: July 24, 2023

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at 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.	Month 12
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   To obtain more information on the study, click here/on this link