deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00263887

Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

Multi-center, Randomized Trial With I.V. Prolastin® to Evaluate Frequency of Exacerbations and Progression of Emphysema by Means of Multi-slice CT Scans in Patients With Congenital Alpha-1-antitrypsin Deficiency.

Sponsor: Grifols Therapeutics LLC

Conditions Alpha 1-Antitrypsin Deficiency
Interventions Albumin (Human) 20%, United States Pharmacopeia (USP) Alpha1-Proteinase Inhibitor (Human)
Updated 8 times since 2017 Last updated: Aug 5, 2014 Started: Dec 31, 2003 Primary completion: Jan 31, 2007 Completion: Jan 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Alpha 1-Antitrypsin Deficiency, this trial is completed. The trial is conducted by Grifols Therapeutics LLC and has accumulated 8 data snapshots since 2003. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Apr 2018 — Jun 2018 [monthly]

    Completed PHASE2

  2. Feb 2017 — Apr 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Dec 2003

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
Data source: Grifols Therapeutics LLC

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

Study Locations