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GLASSIA Safety and Immunogenicity in A1PI Deficiency
NCT02525861Phase 3Completed
- Sponsor
- Takeda
- Start
- Mar 2016
- Primary completion
- Jul 2020
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 2
01
Overview
Phase 3 trial of alpha-1-proteinase inhibitor in alpha-1 antitrypsin deficiency (AATD) (2 cohorts), sponsored by Takeda. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution at Week 26, Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion and 5 more. Started Mar 2016; status: completed.
02
Drugs
alpha-1-proteinase inhibitor
03
Conditions
alpha-1 antitrypsin deficiency (AATD)
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