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

NCT05422365 | Completed Phase 3 Results

• 1 other identifier: 2021-BV-ITP-BP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 12

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.

Conditions

Primary Immune Thrombocytopenia

Keywords

IVIG; ITP; immunomodulatory therapy; intravenous immunoglobulin; chronic primary immune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Part (Percent) of Patients With Response (R)

  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

  28 days after first administration of the study drug

Secondary Outcomes (8)

• Part (Percent) of Patients With Complete Response (CR)

  28 days after first administration of the study drug

• Part (Percent) of Patients With no Response (NR)

  28 days after first administration of the study drug

• Part (Percent) of Patients With Loss of Response (R)

  28 days after first administration of the study drug

• Part (Percent) of Patients With Loss of Complete Response (CR)

  28 days after first administration of the study drug

• Time (in Days) From Treatment Start to Response (R)

  28 days after first administration of the study drug

Other Outcomes (2)

• Frequency (Percent) of Adverse Events

  28 days after first administration of the study drug

• Frequency of Serious Adverse Events

  28 days after first administration of the study drug

Study Arms (1)

Main Group

EXPERIMENTAL

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

Interventions

Intravenous immunoglobulin (IVIG), 10% solution for infusion DRUG

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.

Also known as: Bioven, 10% solution for infusion

Main Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Biopharma Plasma LLC: lead

Study Sites (12)

Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council

Dnipro, 49102, Ukraine

Location

Municipal non-profit enterprise "Khmelnytskyi Regional Hospital" of the Khmelnytskyi Regional Council

Khmelnytskyi, 29010, Ukraine

Location

Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"

Kropyvnytskyi, 25030, Ukraine

Location

Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"

Kyiv, 02091, Ukraine

Location

Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"

Kyiv, 04107, Ukraine

Location

Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 9" of the executive body of the Kyiv City Council (Kyiv City State Administration)

Kyiv, 04112, Ukraine

Location

"Arensia Exploratory Medicine" Limited Liability Company Medical Center

Kyiv, 08112, Ukraine

Location

State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"

Lviv, 79044, Ukraine

Location

Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council

Rivne, 33007, Ukraine

Location

Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"

Sumy, 40031, Ukraine

Location

Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional Council

Ternopil, 46002, Ukraine

Location

Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional Council

Uzhhorod, 88000, Ukraine

Location

Related Links

• Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), rev. 4, 16 December 2021

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Immunoglobulins, Intravenous; Solutions

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Results Point of Contact

• Title: Igor Rudenko, Clinical Research Physician
• Organization: Biopharma Plasma LLC

i.rudenko@biopharma.ua

+380503300865

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, multicenter, international, uncontrolled

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: July 26, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the scientific publication of trial results, 3 months later
• Access Criteria: For specialists in field medicine, pharmacy, scientists

Locations

UA (12)