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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Teduglutide 0.05 mg/kg SC injection.
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Dongcheng, Beijing Municipality, China
RECRUITINGAffiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
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 24
Absolute Change From Baseline in Weekly PS Volume up to Week 24
Time frame: Baseline up to Week 24
Percent Change From Baseline in Weekly PS Volume up to Week 24
Time frame: Baseline up to Week 24
Absolute Change From Baseline in Days Per Week of PS up to Week 24
Time frame: Baseline up to Week 24
Percent Change From Baseline in Days Per Week of PS up to Week 24
Time frame: Baseline up to Week 24
Number of Participants Who Achieved At Least 20% Reduction From Baseline in Weekly PS Volume at each visit
Time frame: Up to Week 24
Number of Participants With At Least a 20% Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24
Time frame: Baseline, Week 20 and Week 24
Number of Participants With At Least a 2-liter Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24
Time frame: Baseline, Week 20 and Week 24
Number of Participants who are able to Completely Wean off of PS support at Week 24
Time frame: At Week 24
Time From First Dose to Time of Completely Weaning off of PS Support
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Zhongshan Hospital, Xiamen University
Siming, Xiamen, China
RECRUITINGTime frame: Up to Week 24
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
Cmax: Maximum Observed Plasma Concentration for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
Tmax: Time to Reach the Cmax for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
T1/2: Terminal Phase Half-life for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
CL/F: Apparent Clearance for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
V/F: Apparent Volume of Distribution During the Terminal Elimination Phase for Teduglutide
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose
Plasma Concentrations of Teduglutide
Time frame: At Week 4 and Week 24
Number of Participants With Positive Antidrug Antibodies (Neutralizing and Non-neutralizing)
Time frame: Baseline, Week 4, and Week 24
Number of Participants Who Experienced At Least One Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Time frame: From first dose of study drug up to follow-up (Week 48)
Change From Baseline in 48-hour Urine Output
Time frame: Baseline up to 48 hours
Change From Baseline in Body Weight
Time frame: Baseline up to Week 48
Change From Baseline in Body Mass Index
Time frame: Baseline up to Week 48