Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Sponsor

Biopharma Plasma LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05422365

Collaborator

(none)

Enrollment

Locations

Arm

16.2

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immune Thrombocytopenia	Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open, multicenter, international, uncontrolledOpen, multicenter, international, uncontrolled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of Bioven, Manufactured by Biopharma Plasma LLC, in Adult Patients With Chronic Primary Immune Thrombocytopenia (ITP)

Actual Study Start Date :

Jul 26, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Main Group 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.	Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg. Other Names: Bioven, 10% solution for infusion

Arm

Intervention/Treatment

Experimental: Main Group

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.

Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion

The study drug is administrated at a dose 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.

Other Names:

Bioven, 10% solution for infusion

Outcome Measures

Primary Outcome Measures

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

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
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 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding
Part (percent) of patients with loss of response (R) [28 days after first administration of the study drug]
platelet count below 30 x 109 /l or less than 2-fold increase of baseline platelet count or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
Part (percent) of patients with loss of complete response (CR) [28 days after first administration of the study drug]
platelet count below 100 x 109 /l or bleeding; platelet counts confirmed on at least 2 separate occasions approximately 1 day apart
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

Other Outcome Measures

Frequency (percent) of adverse events [28 days after first administration of the study drug]
Part of the drug administration cases with adverse events, from all cases of study drug administration
Frequency of serious adverse events [28 days after first administration of the study drug]
Part of the drug administration cases with serious adverse events, from all cases of study drug administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 transaminase levels by more than 3 times the upper limit of normal);
Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
Severe cardiovascular insufficiency (HF III);
History of thrombosis or presence of significant risk factors for thrombosis.
Patients with preventive splenectomy;
Hemostatic disorders other than chronic thrombocytopenia;
Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;
Proven case of primary immunodeficiency;
Secondary immune thrombocytopenia;
Virus infections (Epstein-Barr, Cytomegalovirus, Parvovirus, Hepatitis B and C);
Documented HIV infection
Positive reaction of Wassermann (RW) test result;
Systemic immunopathological diseases (rheumatic diseases, nephritis, etc.);
Oncological diseases;
Diabetes mellitus;
Thyroid diseases;
History of mental illness;
Known drug addiction;
Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
The need to prescribe drugs that are incompatible with the administration of the drug in this study: other immunoglobulin preparations in addition to the study drug, cytostatic drugs, monoclonal antibodies, Avatrombopag);
Experimental treatment (e.g. Rituximab therapy) for 3 months prior to screening);
Blood transfusions or transfusions of blood products in the last 6 months prior to inclusion in the study;
Administration of IVIG 30 days prior to screening;
Participation in any other study currently or within the last 30 days;

Criteria for exclusion of subjects (discontinuation of treatment with the study drug):

Patient's wish
Occurrence of severe and/or unexpected Adverse events (AE) or Adverse reactions (AR) in patient during the study, that require discontinuation of the drug;
The need to prescribe drugs prohibited in this study.
Significant deterioration of the patient's condition during the study period;
Failure of the patient to adhere to the treatment regimen;
Failure of the patient to follow the procedures established under the protocol;

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"	Kropyvnytskyi	Ukraine	25030
2	State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"	Lviv	Ukraine	79044
3	Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council	Rivne	Ukraine	33007
4	Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"	Sumy	Ukraine	40031
5	Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional Council	Ternopil	Ukraine	46002
6	Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional Council	Uzhhorod	Ukraine	88000