Phase 3 N=9 Treatment

A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03268811 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

May 2022

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Teduglutide (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Shire
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs)	7; 2	—
PRIMARY Number of Participants With Clinically Significant Abnormalities in Vital Signs	0; 0	—
PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	5; 1; 1; 0; 0; 0	—
PRIMARY Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment	-37.228; 146.881	—
PRIMARY Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment	24.37; 50.00	—
PRIMARY Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment	-12.678; 206.017	—
PRIMARY Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment	3.143	—
PRIMARY Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment	-7.51; 0.00	—
PRIMARY Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment	5; 0; 4	—
PRIMARY Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing	0; 0	—
PRIMARY Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment	0.229; 3.982	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment	0.002; 1.376	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment	0.152; 3.114	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment	0.098; 3.554	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment	0.126; 3.542	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment	0.342	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment	0.276	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment	0.570	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment	0.851	—
PRIMARY Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment	0.477	—
PRIMARY Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment	2.400	—
PRIMARY Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment	1.431	—
PRIMARY Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment	2.080	—
PRIMARY Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment	2.055	—
PRIMARY Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment	0.090	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment	0.489	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment	0.409	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment	0.118	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment	0.070	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment	0.925	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment	0.839	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment	0.015	—
PRIMARY Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment	0.480	—
SECONDARY Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment	4; 1; 4; 1; 6; 1	—
SECONDARY Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	5; 1; 5; 1; 6; 1	—
SECONDARY Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	-21.5; -31.9; -25.5; -54.2; -32.1; -62.8	—
SECONDARY Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	-39.6; -32.5; -44.3; -56.6; -52.8; -65.6	—
SECONDARY Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	-20.9; -31.3; -28.0; -60.6; -34.8; -67.5	—
SECONDARY Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	-38.8; -32.1; -46.9; -61.4; -55.4; -68.3	—
SECONDARY Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment	1; 0; 1; 0; 1; 0	—
SECONDARY Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	-1.2; 0.0; -1.2; 0.0; -1.2; 0.0	—
SECONDARY Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	-1.2; 0.0; -1.2; 0.0; -16.7; 0.0	—

Summary

The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).

Eligibility Criteria

Inclusion Criteria

Informed consent by a parent or guardian prior to any study-related procedures.
When applicable, informed assent (as deemed appropriate by the Institutional Review Board [IRB]) by the participant prior to any study-related procedures.
Participant completed Study SHP633-302 (NCT02980666).
Participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria

There are no exclusion criteria for this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03268811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.