Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The study will involve patients with chronic immune thrombocytopenia. This disease is
diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only),
except for other reasons. The addition of "chronic" means that the disease lasts more than 12
months.
Patients included in the study will receive Bioven, 10% solution for infusion according to
the protocol for the use of IVIG in ITP - at a dose of 0.8-1.0 g / kg 1 time per day for 2
consecutive days, the course dose of 1.6-2.0 g / kg according to the "Guideline on the
clinical investigation of human normal immunoglobulin for intravenous administration (IVIG)",
rev. 3, 28 June 2018. After administration of the investigational drug, patients will be
under medical supervision for 28 days.
The stay of patients in the study - at least 4 weeks.