The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
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Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)
Timeframe: Baseline, EOT (up to Week 24)
Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)
Timeframe: Baseline, EOT (up to Week 24)
Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24
Timeframe: Week 24
Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)
Timeframe: EOT (up to Week 24)
Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT)
Timeframe: EOT (up to Week 24)
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28
Timeframe: Week 28
Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data
Timeframe: EOT (up to Week 24), EOS (up to Week 28)
Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data
Timeframe: Baseline, EOT (up to Week 24)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to EOS (up to Week 28)
Change From Baseline in Body Weight for Age Z-score at Week 28
Timeframe: Baseline, Week 28
Change From Baseline in Height for Age Z-score at Week 28
Timeframe: Baseline, Week 28
Change From Baseline in Head Circumference for Age Z-score at Week 28
Timeframe: Baseline, Week 28
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to EOS (up to Week 28)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to EOS (up to Week 28)
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to EOS (up to Week 28)
Change From Baseline in the Average Urine Output at Week 28
Timeframe: Baseline, Week 28
Change From Baseline in the Fecal Output at Week 28
Timeframe: Baseline, Week 28
Number of Participants With Positive Specific Antibodies to Teduglutide
Timeframe: From start of study drug administration up to EOS (up to Week 28)
Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing
Timeframe: Baseline, EOT (up to Week 24)
Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Apparent Clearance (CL/F) of Teduglutide
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide
Timeframe: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose