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Octaplas pediatric safety, tolerability, and efficacy study
2018-004686-13Phase 4
- Sponsor
- Octapharma
- Start
- May 2020
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 4, open-label, single-arm trial of fresh-frozen plasma in coagulopathy, acquired clotting factor deficiency (ACFD) and hepatic disease, sponsored by Octapharma. Primary endpoints: Incidence of serious adverse events and predefined safety events and Laboratory safety assessment.
02
Drugs
fresh-frozen plasma
03
Conditions
coagulopathyacquired clotting factor deficiency (ACFD)hepatic disease
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