PMID- 19635187 OWN - NLM STAT- MEDLINE DCOM- 20091015 LR - 20220321 IS - 1607-8454 (Electronic) IS - 1024-5332 (Linking) VI - 14 IP - 4 DP - 2009 Aug TI - Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. PG - 227-36 LID - 10.1179/102453309X439773 [doi] AB - 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. FAU - Robak, T AU - Robak T AD - Department of Hematology, Medical University of Lodz, 2, Ciolkowskiego str., Lodz 93-510, Poland. robaktad@csk.am.lodz.pl FAU - Salama, A AU - Salama A FAU - Kovaleva, L AU - Kovaleva L FAU - Vyhovska, Y AU - Vyhovska Y FAU - Davies, S V AU - Davies SV FAU - Mazzucconi, M G AU - Mazzucconi MG FAU - Zenker, O AU - Zenker O FAU - Kiessling, P AU - Kiessling P CN - International Privigen in ITP Study Group LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - England TA - Hematology JT - Hematology (Amsterdam, Netherlands) JID - 9708388 RN - 0 (Immunoglobulins, Intravenous) RN - 0 (Immunologic Factors) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Blood Platelets/drug effects MH - Child MH - Chronic Disease MH - Female MH - Humans MH - Immunoglobulins, Intravenous/*administration & dosage/adverse effects MH - Immunologic Factors/*administration & dosage/adverse effects MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Platelet Count MH - Prospective Studies MH - Purpura, Thrombocytopenic, Idiopathic/blood/*drug therapy MH - Young Adult FIR - Meyer, O IR - Meyer O FIR - Tretyak, N N IR - Tretyak NN FIR - Kalinina, S Y IR - Kalinina SY FIR - Kyseleva, E A IR - Kyseleva EA FIR - Serbinenko, T IR - Serbinenko T FIR - Dyagil, I S IR - Dyagil IS FIR - Liubarets, T IR - Liubarets T FIR - Kotliarchuk, K B IR - Kotliarchuk KB FIR - Tsyapka, O M IR - Tsyapka OM FIR - Kaplan, P Y IR - Kaplan PY FIR - Yarchuk, E A IR - Yarchuk EA FIR - Sydorenko, I V IR - Sydorenko IV FIR - Selina, I A IR - Selina IA FIR - Rodeghiero, F IR - Rodeghiero F FIR - Ruggeri, M IR - Ruggeri M FIR - Bortolo, S IR - Bortolo S FIR - Morra, E IR - Morra E FIR - Cantoni, S IR - Cantoni S FIR - Bernasconi, S IR - Bernasconi S FIR - Santoro, C IR - Santoro C FIR - Kuliczkowski, K IR - Kuliczkowski K FIR - Podolak-Dawidziak, M IR - Podolak-Dawidziak M FIR - Urbaniak-Kujda, D IR - Urbaniak-Kujda D FIR - Tomaszewska-Toporska, B IR - Tomaszewska-Toporska B FIR - Jedrzejczak, W W IR - Jedrzejczak WW FIR - Niesiobedzka-Krezel, J IR - Niesiobedzka-Krezel J FIR - Tomaszewska, M IR - Tomaszewska M FIR - Karakulska-Prystupik, E IR - Karakulska-Prystupik E FIR - Trelinski, J IR - Trelinski J FIR - Chojnowski, K IR - Chojnowski K FIR - Kloczko, J IR - Kloczko J FIR - Sokolowski, J IR - Sokolowski J FIR - Pawlowska, M IR - Pawlowska M FIR - Zawilska, K IR - Zawilska K FIR - Kasprzak, A IR - Kasprzak A FIR - Karasiewicz, M IR - Karasiewicz M FIR - Prejzner, W IR - Prejzner W FIR - Dutka, M IR - Dutka M FIR - Hellmann, A IR - Hellmann A FIR - Grywacz, A IR - Grywacz A FIR - Kruger, W IR - Kruger W FIR - Johnson, S IR - Johnson S FIR - Bolam, S IR - Bolam S FIR - Allford, S IR - Allford S FIR - Elebute, M IR - Elebute M FIR - Pustovaya, E I IR - Pustovaya EI FIR - Safonova, T I IR - Safonova TI FIR - Abdulkadyrov, K M IR - Abdulkadyrov KM FIR - Litvinskaya, E V IR - Litvinskaya EV FIR - Gritsaev, S V IR - Gritsaev SV FIR - Karyagina, E V IR - Karyagina EV FIR - Shelkovskaya, T IR - Shelkovskaya T FIR - Kharchev, A V IR - Kharchev AV FIR - Zhukova, L Y IR - Zhukova LY FIR - Sokolova, N E IR - Sokolova NE FIR - Petrova, A A IR - Petrova AA FIR - Kehne, J IR - Kehne J FIR - Rubio, A IR - Rubio A FIR - Aledort, L IR - Aledort L FIR - Sayn, H IR - Sayn H FIR - Pichler, W IR - Pichler W FIR - Andresen, I IR - Andresen I FIR - Andresen, C IR - Andresen C EDAT- 2009/07/29 09:00 MHDA- 2009/10/16 06:00 CRDT- 2009/07/29 09:00 PHST- 2009/07/29 09:00 [entrez] PHST- 2009/07/29 09:00 [pubmed] PHST- 2009/10/16 06:00 [medline] AID - 10.1179/102453309X439773 [doi] PST - ppublish SO - Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773.