Abstract |
Intravenous immunoglobulin ( IVIG) has become a mainstay of treatment for acute and chronic immune thrombocytopenic purpura ( ITP). The efficacy and safety of Privigen, a new, ready-to-use, 10% liquid human IgG formulation, was evaluated in this open-label, multicentre study. Privigen infusions (1 g/kg per day for 2 consecutive days, days 1 and 2) were given to 57 adolescent and adult patients with chronic ITP and platelet counts < or =20 x 10(9)/l. By day 7, 80.7% of patients (95% CI, 69.2, 89.3) achieved platelet counts of > or =50 x 10(9)/l. Correspondingly, haemorrhage number and severity were significantly reduced. Adverse events were generally mild or moderate and typical of underlying disease and IVIG treatment. Privigen was well tolerated - 104 of 114 infusions were performed at the maximum permitted infusion rate (4 mg/kg/min). Thus, in patients with chronic ITP, a two-day regimen of Privigen was effective in increasing platelet count, reducing bleeding events and was well tolerated.
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Authors | T Robak, A Salama, L Kovaleva, Y Vyhovska, S V Davies, M G Mazzucconi, O Zenker, P Kiessling, International Privigen in ITP Study Group |
Journal | Hematology (Amsterdam, Netherlands)
(Hematology)
Vol. 14
Issue 4
Pg. 227-36
(Aug 2009)
ISSN: 1607-8454 [Electronic] England |
PMID | 19635187
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Immunoglobulins, Intravenous
- Immunologic Factors
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Topics |
- Adolescent
- Adult
- Aged
- Blood Platelets
(drug effects)
- Child
- Chronic Disease
- Female
- Humans
- Immunoglobulins, Intravenous
(administration & dosage, adverse effects)
- Immunologic Factors
(administration & dosage, adverse effects)
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Platelet Count
- Prospective Studies
- Purpura, Thrombocytopenic, Idiopathic
(blood, drug therapy)
- Young Adult
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