deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT02340819

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

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

Sponsor: Shire

Interventions Teduglutide
Updated 13 times since 2017 Last updated: May 14, 2021 Started: Dec 18, 2014 Primary completion: Nov 5, 2018 Completion: Nov 5, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Short Bowel Syndrome and is currently completed. Shire leads this study, which shows 13 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~May 2019 · 4 months · monthly snapshot~May 2019 – ~Dec 2019 · 7 months · monthly snapshot~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

Show 8 earlier versions
  1. Dec 2019 — Jan 2021 [monthly]

    Completed PHASE3

  2. May 2019 — Dec 2019 [monthly]

    Completed PHASE3

  3. Jan 2019 — May 2019 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Sep 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Dec 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .