Phase 3Completed
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD) (SPARTA)
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1 Proteinase Inhibitor (Human) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency
- Sponsor
- Grifols Therapeutics LLC (Industry)
- Enrolment
- 345 enrolled
- Conditions
- Pulmonary Emphysema in Alpha-1 PI Deficiency
- Interventions
- Alpha-1 MP; 0.9% Sodium Chloride for Injection, USP
- Ages
- adults, older adults
- Registry
- NCT01983241
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline in Whole lung PD15 (15th percentile point)
History
Last registry update
Study completion
Primary completion
Started
Registered