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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2023
  • participants needed
    36
  • sponsor
    Biopharma Plasma LLC
Updated on 4 October 2022

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.

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.

Details
Condition Primary Immune Thrombocytopenia
Treatment Intravenous immunoglobulin (IVIG), 10% solution for infusion
Clinical Study IdentifierNCT05422365
SponsorBiopharma Plasma LLC
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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