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SPARTA-OLE: Long-term Safety of Prolastin-C in Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency
NCT02796937Phase 3Enrolling by invitation
- Sponsor
- Grifols
- Start
- Jul 2016
- Primary completion
- Sep 2028
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 12
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Overview
Phase 3, open-label, single-arm trial of alpha1-proteinase inhibitor in pulmonary emphysema and alpha-1 antitrypsin deficiency (AATD), sponsored by Grifols. Primary endpoints: Adverse Events at 108 weeks, Serious Adverse Events at 108 weeks and 1 more. Started Jul 2016; status: enrolling by invitation.
02
Drugs
alpha1-proteinase inhibitor
03
Conditions
pulmonary emphysemaalpha-1 antitrypsin deficiency (AATD)
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