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Phase 3 Study of Newnorm SCIG in Primary Immunodeficiency
2024-511231-94-00Phase 3Completed
- Sponsor
- Octapharma Pharmazeutika Produktionsgesellschaft mbH
- Start
- Jul 2024
- Modality
- Recombinant Proteins and Enzymes, Antibody-Based Therapeutics
- Countries
- 7
01
Overview
Phase 3, open-label, single-arm trial of Newnorm in Immunogenetic disorder, hypogammaglobulinemia and agammaglobulinemia, sponsored by Octapharma Pharmazeutika Produktionsgesellschaft mbH. Primary endpoints: Rate of serious bacterial infections per person-year and Average total IgG concentration at steady state (Cav). Started Jul 2024; status: completed.
02
Drugs
Newnorm
03
Conditions
Immunogenetic disorderhypogammaglobulinemiaagammaglobulinemia
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