A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Standard of Care	SOC- no teduglutide therapy
Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day

Participant Flow:   Overall Study

	Standard of Care	Teduglutide 0.0125 mg/kg/Day	Teduglutide 0.025 mg/kg/Day	Teduglutide 0.05 mg/kg/Day
STARTED	5	8	14	15
Treated	5	8	14	15
COMPLETED	5	7	14	14
NOT COMPLETED	0	1	0	1
Withdrawal by Subject	0	0	0	1
Protocol Non-compliance	0	1	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Standard of Care	SOC- no teduglutide therapy
Teduglutide 0.0125 mg/kg/Day	Cohort 1 - Teduglutide 0.0125 mg/kg/day
Teduglutide 0.025 mg/kg/Day	Cohort 2 - Teduglutide 0.025 mg/kg/day
Teduglutide 0.05 mg/kg/Day	Cohort 3 - Teduglutide 0.05 mg/kg/day
Total	Total of all reporting groups

Baseline Measures

	Standard of Care	Teduglutide 0.0125 mg/kg/Day	Teduglutide 0.025 mg/kg/Day	Teduglutide 0.05 mg/kg/Day	Total
Overall Participants Analyzed  [Units: Participants]	5	8	14	15	42
Age  [Units: Years] Mean (Standard Deviation)	2.2  (0.45)	5.1  (4.55)	4.6  (3.43)	4.5  (3.16)	4.7  (3.5)
Age, Customized  [Units: Participants]
1 to 3 years	5	4	6	7	22
4 to 12 years	0	3	7	7	17
13 to 17 years	0	1	1	1	3
Gender  [Units: Participants]
Female	2	2	3	7	14
Male	3	6	11	8	28
Region of Enrollment  [Units: Participants]
United States	5	8	14	12	39
United Kingdom	0	0	0	3	3

1.  Primary:

Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:

Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment   [ Time Frame: Baseline, End of Treatment ]

3.  Primary:

Percent Change in Parenteral Support (PN/IV) Volume at Week 16   [ Time Frame: Baseline, Week 16 ]

4.  Primary:

Absolute Change in Parenteral Support (PN/IV) Volume at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Primary:

Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment   [ Time Frame: Baseline, End of Treatment ]

6.  Primary:

Absolute Change in Parenteral Support (PN/IV) Volume at Week 16   [ Time Frame: Baseline, Week 16 ]

7.  Other Pre-specified:

Percent Change in Enteral Support (EN) Volume From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

8.  Other Pre-specified:

Percent Change in Enteral Support (EN) Volume From Baseline at Week 16   [ Time Frame: Baseline, Week 16 ]

9.  Other Pre-specified:

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Other Pre-specified:

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16   [ Time Frame: Baseline, Week 16 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.