Efficacy and safety of a new intravenous immunoglobulin (Panzyga((R))) in chronic immune thrombocytopenia
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F19%3A00070814" target="_blank" >RIV/65269705:_____/19:00070814 - isvavai.cz</a>
Result on the web
<a href="https://onlinelibrary.wiley.com/doi/full/10.1111/tme.12573" target="_blank" >https://onlinelibrary.wiley.com/doi/full/10.1111/tme.12573</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1111/tme.12573" target="_blank" >10.1111/tme.12573</a>
Alternative languages
Result language
angličtina
Original language name
Efficacy and safety of a new intravenous immunoglobulin (Panzyga((R))) in chronic immune thrombocytopenia
Original language description
Objectives To assess the efficacy and safety of intravenous immunoglobulin (IVIG) 10% (Panzyga((R))), a novel human normal IVIG 10%, in patients with chronic immune thrombocytopenia (ITP). Background First-line treatment options in ITP include IVIGs. Methods In this prospective, open-label, non-controlled, multicentre, phase III study, patients received a daily dose of IVIG 10% (1 g kg(-1) body weight) for two consecutive days. The primary end point was clinical response rate; secondary end points included alternate response definitions, time to response, response duration, platelet counts, regression of bleeding and safety. Results Forty patients were enrolled (57 center dot 5% male, mean age 36 center dot 7 years); the full analysis set comprised 36 patients. A clinical response was seen for 29 of 36 patients (80 center dot 6%). Median time to response and response duration was 2 days and 14 days, respectively. IVIG 10% was well tolerated at a maximum infusion rate of 8 mg (kg min)(-1) in all but one patient; adverse events were mainly mild to moderate in severity, and the most frequent was headache (42 center dot 5%). Conclusion IVIG 10% is well tolerated even at a high infusion speed and induces a rapid platelet count increase, thus decreasing the bleeding rate and the severity of bleeding events. Trial registry: record: NCT01349790.
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30205 - Hematology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Transfusion Medicine
ISSN
0958-7578
e-ISSN
—
Volume of the periodical
29
Issue of the periodical within the volume
1
Country of publishing house
US - UNITED STATES
Number of pages
7
Pages from-to
48-54
UT code for WoS article
000460783700009
EID of the result in the Scopus database
2-s2.0-85060731082