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Completed

NCT Number: NCT02340819

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

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).

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tohoku University Hospital, Sendai, Aoba-ku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teduglutide

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  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)

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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)

    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)

    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)

    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)

    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)

    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

  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

    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

    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

    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

    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

    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

    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

    Apparent volume of distribution of teduglutide in plasma were evaluated.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2015
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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