deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01598831

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.

Sponsor: Asahi Kasei Pharma America Corporation

Conditions Coagulopathy Severe Sepsis
Interventions ART-123 Placebo
Updated 16 times since 2017 Last updated: Apr 18, 2020 Started: Oct 29, 2012 Primary completion: Apr 5, 2018 Completion: Feb 28, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01598831, this PHASE3 trial focuses on Coagulopathy and Severe Sepsis and remains completed. Sponsored by Asahi Kasei Pharma America Corporation, it has been updated 16 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jan 2018 · 5 months · monthly snapshot~Jan 2018 – ~Apr 2018 · 3 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshot~Jan 2019 – ~Jul 2019 · 6 months · monthly snapshot~Jul 2019 – ~May 2020 · 10 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 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

16 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. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

▶ Show 11 earlier versions

  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Jul 2019 — May 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Jan 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. Jan 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

  9. Aug 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  10. Feb 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Asahi Kasei Pharma America Corporation
Data source: Asahi Kasei Pharma America Corporation

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

Study Locations

's-Hertogenbosch, Netherlands , A Coruña, Spain , Aachen, Germany , Adelaide, Australia , Ahmedabad, India , Amsterdam, Netherlands , Angers, France , Antwerp, Belgium , Arkhangelsk, Russia , Arlon, Belgium and 121 more locations