Clinical Trial

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Study acronym: SPARTA
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
Protocol Amendment History 41 amendments
This ClinicalTrials.gov record has been amended 41 times since 2013-11-07; most recent amendment 2026-06-18.
Status change: Recruiting → Active, Not Recruiting 2023-06-22
Status change: Not Yet Recruiting → Recruiting 2013-11-26
Trial Details
NCT Number NCT01983241
Lead Sponsor Grifols Therapeutics LLC
Conditions Pulmonary Emphysema in Alpha-1 PI Deficiency
Enrollment 345 participants
Start Date 2013-11
Primary Completion 2026-08 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-23