A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
ConditionShort Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide.
Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment.
Participants will be in the study for about 65 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females 18 years of age or older at the time of signing the informed consent.
Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).
Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption.
Disqualifiers
Pregnant or lactating female.
Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study.
Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.
Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
Trial design
Design model
Single group
Treatments tested in this trial
Teduglutide
DrugTeduglutide 0.05 mg/kg SC injection.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Teduglutide 0.05 milligram per kilogram (mg/kg)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 and Maintained Through Week 24
Time frame
Up to Week 24Secondary outcomes
1
Absolute Change From Baseline in Weekly PS Volume up to Week 24
Time frame
Baseline up to Week 242
Percent Change From Baseline in Weekly PS Volume up to Week 24
Time frame
Baseline up to Week 243
Absolute Change From Baseline in Days Per Week of PS up to Week 24
Time frame
Baseline up to Week 244
Percent Change From Baseline in Days Per Week of PS up to Week 24
Time frame
Baseline up to Week 24 Source ClinicalTrials.gov