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

Takeda65 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Short Bowel Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

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.

Time frame: Month 1

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.

Time frame: Month 2

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.

Time frame: Month 3

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.

Time frame: Month 6

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.

Time frame: Month 9

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation

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.

Time frame: Baseline up to Month 24

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.

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 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.

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

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.

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

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.

Time frame: 6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation

Median Time to Achieve any Response After Teduglutide Treatment Initiation.

Median time to achieve any response after teduglutide treatment initiation will be assessed.

Time frame: Up to Month 24

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.

Time frame: Up to Month 24

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.

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 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.

Time frame: 6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation

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.

Time frame: 6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation

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.

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 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.

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 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.

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 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.

Time frame: Up to Month 6 after teduglutide treatment discontinuation

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.

Time frame: Up to Month 24