Phase 3
Completed N=11
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Source: ClinicalTrials.gov NCT02340819 ↗
Enrolled (actual)
11
Serious AEs
63.6%
Results posted
Nov 2019
Primary outcomePrimary: Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 — -4.92 Liter per week (L/week)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 |
-4.92 | — |
| PRIMARY Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 |
-30.07 | — |
| PRIMARY Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 |
45.5; 54.5 | — |
| PRIMARY Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 |
-1.0 | — |
| PRIMARY Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24 |
15.0 | — |
| PRIMARY Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24 |
86.9 | — |
| PRIMARY Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24 |
— | — |
| PRIMARY Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 |
-8.33 | — |
| PRIMARY Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 |
-53.53 | — |
| PRIMARY Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24 |
-2.1 | — |
| PRIMARY Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24 |
28.3 | — |
| PRIMARY Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24 |
135.0 | — |
| PRIMARY Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment |
-5.08 | — |
| PRIMARY Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment |
-34.12 | — |
| PRIMARY Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment |
-1.4 | — |
| PRIMARY Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment |
19.3 | — |
| PRIMARY Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment |
110.3 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma |
204 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma |
201 | — |
| SECONDARY Maximum Concentration (Cmax) of Teduglutide in Plasma |
49.7 | — |
| SECONDARY Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma |
2.49 | — |
| SECONDARY Terminal Half-Life (t1/2) of Teduglutide in Plasma |
1.06 | — |
| SECONDARY Apparent Clearance (CL/F) of Teduglutide in Plasma |
14.5 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma |
27.8 | — |
Eligibility Criteria
This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a 24-week treatment period in which all patients will receive teduglutide (Stage 2), and a long-term extension (Stage 3).
During the long-term extension (Stage 3), patients will continue to receive teduglutide for up to an additional 24 months or until teduglutide is commercially available, whichever comes earlier.
Data sourced from ClinicalTrials.gov (NCT02340819). 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. Informational only — not medical advice.