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Long-term safety of weekly alpha-1 proteinase inhibitor (human), modified process 60 mg/kg in alpha-1 antitrypsin deficiency emphysema
2024-513962-20-00Phase 3Authorised
- Sponsor
- Grifols
- Start
- Aug 2024
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 11
01
Overview
Phase 3, open-label, single-arm trial of alpha-1-proteinase inhibitor in alpha-1 antitrypsin deficiency emphysema, sponsored by Grifols. Primary endpoints: Whole lung 15th percentile point (PD15) using CT densitometry, Carbon monoxide diffusing capacity (DLCO) and 4 more. Planned start Aug 2024; status: authorised.
02
Drugs
alpha-1-proteinase inhibitor
03
Conditions
alpha-1 antitrypsin deficiency emphysema
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