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Long-term Safety of TAK-771 in Japanese Patients with Primary Immunodeficiency Disease
jRCT2041220059Phase 3Completed
- Sponsor
- Takeda
- Start
- Sep 2022
- Modality
- Therapeutic Enzymes → Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of immunoglobulin g + hyaluronidase in Immunogenetic disorder, sponsored by Takeda. Primary endpoints: Percentage of participants with treatment-emergent adverse events (TEAEs) and Percentage of participants who develop anti-rHuPH20 binding antibody titers ≥1:160 and who develop neutralizing antibodies to rHuPH20. Started Sep 2022; status: completed.
02
Drugs
immunoglobulin g + hyaluronidase
03
Conditions
Immunogenetic disorder
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