Clinical Trial

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

Study acronym: SPARTA-OLE
Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
Summary
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2016-06-07; most recent amendment 2026-06-18.
Status change: Recruiting → Enrolling by Invitation 2022-11-16
Status change: Active, Not Recruiting → Recruiting 2022-09-20
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-04-05
Trial Details
NCT Number NCT02796937
Lead Sponsor Grifols Therapeutics LLC
Conditions Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
Enrollment 290 participants
Start Date 2016-07
Primary Completion 2028-09 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-23