Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocy… (NCT05422365) | Clinical Trial Compass
CompletedPhase 3
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults
Ukraine32 participantsStarted 2022-07-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria:
* Signed Patient Informed Consent Form for participation in the study;
* Men and women aged 18-65;
* Confirmed primary chronic ITP (lasting \> 12 months since diagnosis);
* A full blood count should be normal except for the isolated thrombocytopenia. Patients with low hemoglobin levels (but above 90 g / l) may be included if there are symptoms of bleeding;
* If bleeding symptoms are diagnosed, the reticulocyte count should be measured;
* Platelet count \<30 x 109 / L;
* If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening);
* Negative pregnancy test (for women of child-bearing potential);
* Willingness to use effective and reliable methods of contraception throughout the entire study period;
* The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant;
* Ability, according to the researcher, to follow all the requirements of the study protocol;
Exclusion criteria:
* Known intolerance to plasma and immunoglobulin preparations;
* Drug allergy or hypersensitivity to immunoglobulin preparations;
* Confirmed deficiency of immunoglobulin A (IgA) and antibodies to IgA.
* Contraindications to immunoglobulin administration according to the instructions for medical use;
* Pregnancy and lactation;
* Any clinically significant hepatic impairment (increase of serum tr…
What they're measuring
1
Part (Percent) of Patients With Response (R)
Timeframe: 28 days after first administration of the study drug