Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura.
Hematology
; 14(4): 227-36, 2009 Aug.
Article
in En
| MEDLINE
| ID: mdl-19635187
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Purpura, Thrombocytopenic, Idiopathic
/
Immunoglobulins, Intravenous
/
Immunologic Factors
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Hematology
Journal subject:
HEMATOLOGIA
Year:
2009
Document type:
Article
Affiliation country:
Poland