Clinical trial

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

NCT00263887 · Grifols Therapeutics LLC, Industry · Completed

Key facts

NCT number NCT00263887
Title Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
Official title 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.
Lead sponsor Grifols Therapeutics LLC, Industry
Status Completed
Phase Phase 2
Study type Interventional
Conditions Alpha 1-Antitrypsin Deficiency
Intervention type Drug
Interventions Alpha1-Proteinase Inhibitor (Human), Albumin (Human) 20%, United States Pharmacopeia (USP)
Enrollment 77
Start date Dec 1, 2003
Primary completion Jan 1, 2007
Completion Jan 1, 2007
First posted Dec 9, 2005
Last update posted Aug 21, 2014
Countries Denmark, Sweden, United Kingdom

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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