deltatrials
Terminated PHASE3 INTERVENTIONAL 5-arm NCT02722304

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

A Stage 1, Prospective, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Safety and Efficacy of Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)

Sponsor: Baxalta Innovations GmbH, now part of Shire

Conditions Alpha1-antitrypsin Deficiency Chronic Obstructive Pulmonary Disease
Interventions ARALAST NP 120 mg/kg ARALAST NP 60 mg/kg GLASSIA 120 mg/kg GLASSIA 60 mg/kg Human Albumin 2%
Updated 16 times since 2017 Last updated: Apr 17, 2021 Started: Nov 2, 2016 Primary completion: Sep 14, 2018 Completion: Sep 14, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

Other terminated trials from Baxalta Innovations GmbH, now part of Shire

See all terminations from Baxalta Innovations GmbH, now part of Shire

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Listed as NCT02722304, this PHASE3 trial focuses on Alpha1-antitrypsin Deficiency and Chronic Obstructive Pulmonary Disease and remains terminated or withdrawn. Sponsored by Baxalta Innovations GmbH, now part of Shire, it has been updated 16 times since 2016, 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 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Sep 2017 · 2 months · monthly snapshot~Sep 2017 – ~Nov 2017 · 2 months · monthly snapshot~Nov 2017 – ~Feb 2018 · 3 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Nov 2019 · 11 months · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Jan 2021 · 12 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jun 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  5. Jan 2021 — Jun 2021 [monthly]

    Terminated PHASE3

▶ Show 11 earlier versions

  1. Jan 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  2. Nov 2019 — Jan 2020 [monthly]

    Terminated PHASE3

  3. Dec 2018 — Nov 2019 [monthly]

    Terminated PHASE3

    Status: Recruiting → Terminated · Phase: PHASE4 → PHASE3

  4. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE4

  5. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  6. Nov 2017 — Feb 2018 [monthly]

    Recruiting PHASE4

  7. Sep 2017 — Nov 2017 [monthly]

    Recruiting PHASE4

  8. Jul 2017 — Sep 2017 [monthly]

    Recruiting PHASE4

  9. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE4

  10. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE4

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE4

    First recorded

Nov 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Baxalta Innovations GmbH, now part of Shire
  • Baxalta now part of Shire
Data source: Takeda

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

Study Locations

Allen, United States , Fayetteville, United States , Fitzroy, Australia , Gastonia, United States , Houston, United States , Indianapolis, United States , Kissimmee, United States , London, Canada , Maywood, United States , Miami, United States and 7 more locations