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pro.LISA
2024-516504-42-00Phase 3Authorised
- Sponsor
- Universitätsklinikum Schleswig-Holstein
- Start
- Jul 2024
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, single-blind trial of Poractant alfa and calfactant in respiratory distress syndrome (RDS) (2 arms), sponsored by Universitätsklinikum Schleswig-Holstein. Primary endpoint: Forced expiratory volume in 1 second (FEV1) z-score at 5 years. Planned start Jul 2024; status: authorised.
02
Drugs
Poractant alfacalfactant
03
Conditions
respiratory distress syndrome (RDS)
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