Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults
- Conditions
- Primary Immune Thrombocytopenia
- Interventions
- Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion
- Registration Number
- NCT05422365
- Lead Sponsor
- Biopharma Plasma LLC
- Brief 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.
- Detailed Description
The investigational drug, IVIG, is used for immunomodulatory therapy in the treatment of autoimmune diseases.
The study will involve patients with chronic immune thrombocytopenia. This autoimmune 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.
Screening stage The patient or her legal representative must sign an informed consent. After the informed consent signing procedure, the patient is screened and assessed for compliance with the inclusion and non-inclusion (exclusion) criteria.
Clinical stage After the patient is included in the study, according to the protocol, he/she is hospitalized and the study drug is administered at a dose of 0.8-1.0 g/kg once a day for 2 days (the course dose is 1.6-2.0 g/kg). The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG) and the Coombs test. This procedure will also be carried out on days 7, 14, 21 and 28 after the first injection of the drug to monitor the patient's performance.
The final stage The blood sampling procedure to determine the above indicators will be carried out on days 7, 14, 21, and 28 after the first administration of the drug to monitor the patient's performance.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Main Group Intravenous immunoglobulin (IVIG), 10% solution for infusion Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test. This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance.
- Primary Outcome Measures
Name Time Method Part (Percent) of Patients With Response (R) 28 days after first administration of the study drug platelet count \>30 x 109 /l and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
- Secondary Outcome Measures
Name Time Method Part (Percent) of Patients With Complete Response (CR) 28 days after first administration of the study drug platelet count \>100 x 109 /l, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding. Complete response (CR) was achieved in 13 patients during the study.
CR = 13/32 = 40.63 % (23,61%; 57,64%) This corresponds 40,63% from total number of patients. The confidence interval for this value is 23.61% to 57.64%Part (Percent) of Patients With no Response (NR) 28 days after first administration of the study drug platelet count \< 30 x 109/L or less than a 2-fold increase of the baseline count. It should be confirmed by at least 2 blood tests or presence of bleeding
Part (Percent) of Patients With Loss of Response (R) 28 days after first administration of the study drug Decreasing platelet count (\< 30 x 109/L or less than a 2-fold increase of the baseline count) or development of bleeding. Platelet count should be confirmed at least two times, with an interval of 1 day.
Part (Percent) of Patients With Loss of Complete Response (CR) 28 days after first administration of the study drug decreased platelet count \<100 x 109/L or development of bleeding
Time (in Days) From Treatment Start to Response (R) 28 days after first administration of the study drug Time calculated from first infusion (treatment start) to the day when the response (R) criteria are achieved
Time (in Days) From Treatment to Complete Response (CR) 28 days after first administration of the study drug Time calculated from first infusion (treatment start) to the day when the complete response (CR) criteria are achieved
Duration (in Days) of Response (R) 28 days after first administration of the study drug Time calculated from the day when the complete response (R) criteria are achieved, to the day when loss of complete response (R) criteria is achieved
Duration (in Days) of Complete Response (CR) 28 days after first administration of the study drug Time calculated from the day when the complete response (CR) criteria are achieved, to the day when loss of complete response (CR) criteria are achieved
Trial Locations
- Locations (12)
Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council
🇺🇦Dnipro, Ukraine
Municipal non-profit enterprise "Khmelnytskyi Regional Hospital" of the Khmelnytskyi Regional Council
🇺🇦Khmelnytskyi, Ukraine
Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"
🇺🇦Kropyvnytskyi, Ukraine
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
🇺🇦Kyiv, Ukraine
Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
🇺🇦Kyiv, Ukraine
Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 9" of the executive body of the Kyiv City Council (Kyiv City State Administration)
🇺🇦Kyiv, Ukraine
"Arensia Exploratory Medicine" Limited Liability Company Medical Center
🇺🇦Kyiv, Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"
🇺🇦Lviv, Ukraine
Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council
🇺🇦Rivne, Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"
🇺🇦Sumy, Ukraine
Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional Council
🇺🇦Ternopil, Ukraine
Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional Council
🇺🇦Uzhhorod, Ukraine