Phase 3 N=11 Treatment

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02340819 ↗

Enrolled (actual)

Serious AEs

63.6%

Results posted

Nov 2019

Primary outcome: Primary: Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 — -4.92 Liter per week (L/week)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Teduglutide (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Shire
Primary completion: Nov 2018

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	—

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).

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.

View full record on ClinicalTrials.gov →

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.