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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02340819 (opens ClinicalTrials.gov in a new tab)Other idTED-C14-004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
11 participants (actual)
Sponsor
Shire · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Japan

Start
18 Dec 2014
Primary completion
5 Nov 2018
Completion
5 Nov 2018
First posted
19 Jan 2015 (estimated)
Last update posted
9 Jun 2021
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 3

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

    NCT02340819

    18 Dec 2014 to 5 Nov 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • TeduglutideDrug

Arms1

  • Experimental

    Arm 1

    0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.

Primary outcomes17

Outcomes the sponsor listed as primary.

  1. Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

    Time frame · Baseline (stage 2), Week 24

    Registry description

    Absolute change from baseline in weekly PS volume at Week 24 was reported.

  2. Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

    Time frame · Baseline (stage 2), Week 24

    Registry description

    Percent change from baseline in weekly PS volume at Week 24 was reported.

  3. 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)

    Registry description

    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.

  4. 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

    Registry description

    Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.

  5. Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24

    Time frame · Baseline (stage 2), Week 24

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.

  6. Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24

    Time frame · Baseline (stage 2), Week 24

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.

  7. Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24

    Time frame · Week 24

    Registry description

    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.

  8. Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24

    Time frame · Baseline (stage 3), Extension Month 24

    Registry description

    Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.

  9. Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24

    Time frame · Baseline (stage 3), Extension Month 24

    Registry description

    Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.

  10. Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24

    Time frame · Baseline (stage 3), Extension Month 24

    Registry description

    Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.

  11. Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24

    Time frame · Baseline (stage 3), Extension Month 24

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.

  12. Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24

    Time frame · Baseline (stage 3), Extension Month 24

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.

  13. Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment

    Time frame · Baseline (stage 4), End of Treatment (up to 47 months)

    Registry description

    Absolute change from baseline in weekly PS volume at end of treatment was reported.

  14. Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment

    Time frame · Baseline (stage 4), End of Treatment (up to 47 months)

    Registry description

    Percent change from baseline in weekly PS volume at end of treatment was reported.

  15. Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment

    Time frame · Baseline (stage 4), End of Treatment (up to 47 months)

    Registry description

    Absolute change from baseline in number of days per week of PS usage at end of treatment was reported.

  16. Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment

    Time frame · Baseline (stage 4), End of Treatment (up to 47 months)

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported.

  17. Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment

    Time frame · Baseline (stage 4), End of Treatment (up to 47 months)

    Registry description

    Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported.

Secondary outcomes(7)

  1. 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

    Registry description

    Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated.

  2. 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

    Registry description

    Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated.

  3. 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

    Registry description

    Maximum concentration of teduglutide in plasma were evaluated.

  4. 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

    Registry description

    Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated.

  5. 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

    Registry description

    Terminal half-life of teduglutide in plasma were evaluated.

  6. 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

    Registry description

    Apparent clearance of teduglutide in plasma were evaluated.

  7. 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

    Registry description

    Apparent volume of distribution of teduglutide in plasma were evaluated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (stage 2), Week 24

Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

GroupValue (Liter per week (L/week))Spread
Teduglutide-4.924.749
Primary outcomeMean· Baseline (stage 2), Week 24

Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

GroupValue (Percent change in PS volume)Spread
Teduglutide-30.0725.892
Primary outcomeNumber· End of Stage 2 (up to Week 24)

Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2

GroupValue (Percentage of Participants)
Teduglutide45.5
Primary outcomeMean· Baseline (stage 2), Week 24

Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24

GroupValue (Days per week (days/week))Spread
Teduglutide-1.01.80
Primary outcomeMean· Baseline (stage 2), Week 24

Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24

GroupValue (Micromoles per liter)Spread
Teduglutide15.017.37
Primary outcomeMean· Baseline (stage 2), Week 24

Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24

GroupValue (Percent change)Spread
Teduglutide86.9112.33
Primary outcomeCount of participants· Week 24

Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24

GroupValue (Participants)
Teduglutide0
Primary outcomeMean· Baseline (stage 3), Extension Month 24

Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24

GroupValue (L/week)Spread
Teduglutide-8.335.940

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeduglutideOptimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued.1 / 117 / 1111 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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