期刊
HEMATOLOGY
卷 15, 期 5, 页码 351-359出版社
MANEY PUBLISHING
DOI: 10.1179/102453310X12719010991867
关键词
Bleeding; immune thrombocytopenia; intravenous immunoglobulin; platelet count; octagam 10%
类别
资金
- Octapharma
Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam (R) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count (<= 20 x 10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0.12 ml/kg/minute. Eighty per cent of patients attained the primary efficacy endpoint of clinical response (platelet count >= 50 x 10(9)/l within 6 days of dosing). The median time to response was 2 days and the median duration of response was 12 days; mean response duration was 24.1 days. octagam 10% was well tolerated and effective in this population representative of adult patients with ITP, even at the maximum infusion rate of 0.12 ml/kg/minute, without unexpected safety issues.
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