DRUG
Teduglutide
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
Status
Completed
Phase
Phase 3
Enrollment
11
Locations
5
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 19, 2015
Study start
Dec 18, 2014
Primary completion
Nov 5, 2018
Study completion
Nov 5, 2018
Results posted
Nov 20, 2019
Registry updated
Jun 9, 2021
Outcomes
What the study measures.
Primary outcomes
Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame · Baseline (stage 2), Week 24
Absolute change from baseline in weekly PS volume at Week 24 was reported.
Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame · Baseline (stage 2), Week 24
Percent change from baseline in weekly PS volume at Week 24 was reported.
Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2
Time frame · End of Stage 2 (up to Week 24)
Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24.
Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24
Time frame · Baseline (stage 2), Week 24
Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.
Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24
Time frame · Baseline (stage 2), Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.
Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24
Time frame · Baseline (stage 2), Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.
Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24
Time frame · Week 24
Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported.
Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Time frame · Baseline (stage 3), Extension Month 24
Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Secondary outcomes
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated.
Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated.
Maximum Concentration (Cmax) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Maximum concentration of teduglutide in plasma were evaluated.
Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated.
Terminal Half-Life (t1/2) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Terminal half-life of teduglutide in plasma were evaluated.
Apparent Clearance (CL/F) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent clearance of teduglutide in plasma were evaluated.
Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma
Time frame · Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent volume of distribution of teduglutide in plasma were evaluated.
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
5 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Tohoku University Hospital
Sendai, Aoba-ku, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Hodogaya-ku, Japan
Hospital of Hyogo College of Medicine
Hyōgo, Nishinomiya, Japan
Osaka University Hospital, Department of Gastroenterological Surgery
Osaka, Suita, Japan
Osaka University Hospital, Department of Pediatric Surgery
Osaka, Suita, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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