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Weekly subcutaneous versus intravenous alpha1-proteinase inhibitor pharmacokinetic study in alpha1-antitrypsin deficiency
2025-522792-29-00Phase 3Authorised
- Sponsor
- Grifols
- Start
- May 2026
- Modality
- Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes, Recombinant Proteins and Enzymes
- Countries
- 10
01
Overview
Phase 3, randomised, open-label trial of prolastin-c liquid and alpha1-proteinase inhibitor in alpha-1 antitrypsin deficiency (AATD) (2 arms), sponsored by Grifols. Primary endpoint: Steady-state alpha1-PI AUC over weekly dosing interval. Planned start May 2026; status: authorised.
02
Drugs
prolastin-c liquidalpha1-proteinase inhibitor
03
Conditions
alpha-1 antitrypsin deficiency (AATD)
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