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- W2913797731 abstract "Intravenous (IV) C1-INH concentrate (Shire, USA) is approved for long-term prophylaxis against HAE attacks in patients with C1 esterase inhibitor (C1-INH) deficiency aged ≥6 years in the European Union (for severe and recurrent attacks) and the United States. Safety, efficacy, and pharmacokinetic (PK) data from three clinical trials of C1-INH for HAE attack prevention in children are presented. Safety and efficacy data from two phase 3 efficacy and safety trials of IV C1-INH, one in patients aged ≥6 years (NCT01005888), another specifically targeting patients aged 6-11 years (NCT02052141), and an open-label trial in patients aged ≥1 years (NCT00462709) were analyzed. Eligible patients in these studies had an attack frequency of ≥1 to ≥ 2 attacks/month or any laryngeal edema. Fixed doses ranged from 500 to 1000 U administered every 3-4 or 3-7 days. Study NCT02052141 also collected PK data. Of 296 treatment-emergent adverse events (TEAEs) in 22 children aged 6-11 years who received 1493 infusions, 41 were possibly related to C1-INH (fatigue, irritability, HAE attack, diarrhea, erythema, pruritus, pyrexia, dizziness, mouth ulceration, headache, and nausea), all mild or moderate in severity. No serious adverse events were related to C1-INH and no TEAEs led to drug discontinuation. Compared with baseline, children aged 6-11 years had a 78.9-84.5% reduction in their number of HAE attacks with 1000 U C1-INH. There was no observed accumulation of C1-INH with multiple doses. When used for long-term prophylaxis of HAE attacks in children, IV C1-INH concentrate was safe, well tolerated, and effective." @default.
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- W2913797731 date "2019-02-01" @default.
- W2913797731 modified "2023-10-17" @default.
- W2913797731 title "Safety, efficacy, and pharmacokinetics of intravenous C1 esterase inhibitor (human) prophylaxis in children with hereditary angioedema (HAE)" @default.
- W2913797731 doi "https://doi.org/10.1016/j.jaci.2018.12.125" @default.
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