A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
ConditionShort Bowel Syndrome (SBS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorTakeda
About this trial
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is.
The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS.
The study will review data already existing in the medical records of participants as well as collect new data during the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents greater than or equal to (>=)1 through 17 years of age at Day 1 (D1).
Documented diagnosis of SBS.
Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.
Stable PN/IV support, defined as inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (i.e., 10% or less change in PN or advance in feeds) for at least 3 months prior to D1, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
Disqualifiers
Participants who are not expected to be able to advance oral or tube feeding regimens.
Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
Trial population
The study population consists of Chinese pediatric participants with SBS who are dependent on PS.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No Intervention
Other interventionNo Intervention
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Retrospective Group1 intervention
Group B: Mixed Group1 intervention
Group C: Prospective Group1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Percentage of participants who achieve at least a 20 percent (%) reduction from baseline in weekly PS volume at Week 24 will be reported.
Time frame
At Week 24Secondary outcomes
1
Number of Participants Able to Completely Wean off PS Support at Week 24
Number of participants who are able to completely wean off PS support at Week 24 will be reported.
Time frame
At Week 242
Absolute Change from Baseline in PN/Intravenous (IV) Support Volume
Absolute change from baseline in PN/IV support volume will be reported.
Time frame
Baseline up to Week 243
Percent Change From Baseline in PN/IV Support Volume
Percent change from baseline in PN/IV support volume will be reported.
Time frame
Baseline up to Week 244
Absolute Change From Baseline in PN/IV Support Calories
Absolute change from baseline in PN/IV support calories will be reported.
Time frame
Baseline up to Week 24 Source ClinicalTrials.gov