Phase 3
N=61
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02954458 ↗Enrolled (actual)
61
Serious AEs
78.7%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 6; 3; 1; 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TED (Drug); SOC (Other); Syringe (Device); Needle (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
6; 3; 1; 50 | — |
| PRIMARY Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment |
0.26; 2.51 | — |
| PRIMARY Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) |
-0.89; 15.01; -6.87 | — |
| PRIMARY Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment |
-0.47 | — |
| PRIMARY Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT) |
-0.50; 0.38 | — |
| PRIMARY Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment |
0.00; -11.35 | — |
| PRIMARY Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT) |
0.31; -4.98 | — |
| PRIMARY Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment |
-12.52; 12.16 | — |
| PRIMARY Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT) |
23.89 | — |
| PRIMARY Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment |
-0.54 | — |
| PRIMARY Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT) |
-0.25; 0.00; -0.08 | — |
| PRIMARY Number of Participants With Positive Specific Antibodies at End of Study (EOS) |
2; 0; 10 | — |
| PRIMARY Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment |
0.087; -0.164 | — |
| PRIMARY Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT) |
-0.489; -0.132; 0.013; -0.363 | — |
| PRIMARY Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment |
0.118; -0.277 | — |
| PRIMARY Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment |
-0.518; -0.770; 0.220; -0.132 | — |
| PRIMARY Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment |
-0.727 | — |
| PRIMARY Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT) |
-0.309 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment |
0.215; 0.035 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT) |
-0.545; 0.791; -0.564; -0.148 | — |
| SECONDARY Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment |
1; 29; 0; 13; 0; 7 | — |
| SECONDARY Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment |
2; 35; 0; 18; 0; 9 | — |
| SECONDARY Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment |
-14.87; -22.63; -8.98; -25.75; -34.81; -32.01 | — |
| SECONDARY Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment |
-23.23; -41.88; -13.29; -45.67; -38.66; -46.62 | — |
| SECONDARY Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment |
-22.57; -20.87; -65.88; -24.24; -58.82; -30.53 | — |
| SECONDARY Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment |
-28.82; -34.43; -73.03; -42.38; -67.01; -44.07 | — |
| SECONDARY Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment |
-16.95; -17.40; -10.46; -18.71; -20.77; -22.09 | — |
| SECONDARY Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment |
-35.21; -45.91; -14.63; -48.66; -29.03; -46.75 | — |
| SECONDARY Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment |
-16.94; -15.80; -37.91; -16.00; -44.01; -20.18 | — |
| SECONDARY Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment |
-34.79; -40.67; -50.00; -42.75; -59.00; -44.74 | — |
| SECONDARY Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment |
0; 7; 0; 8; 0; 6 | — |
| SECONDARY Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-0.57; -3.58; -1.71; -3.55; -3.57; -4.19 | — |
| SECONDARY Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-4.76; -33.43; -14.29; -34.12; -26.98; -35.11 | — |
| SECONDARY Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment |
0.00; -2.60; -3.00; -2.78; -1.00; -2.79 | — |
| SECONDARY Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment |
0.00; -21.27; -16.67; -22.75; -5.56; -20.64 | — |
| SECONDARY Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-0.33; -1.41; -1.00; -1.76; -1.50; -2.13 | — |
| SECONDARY Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-4.76; -23.40; -14.29; -29.07; -21.43; -31.37 | — |
| SECONDARY Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-0.33; -1.42; -1.00; -1.65; -1.50; -1.85 | — |
| SECONDARY Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment |
-4.76; -23.18; -14.29; -27.41; -21.43; -27.58 | — |
Summary
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.
Eligibility Criteria
Inclusion Criteria
- Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
- Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
- Participant 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.
Data sourced from ClinicalTrials.gov (NCT02954458). 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.