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Primary Immune ThrombocytopeniaPhase 3NCT05422365

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

A Phase 3 study testing Intravenous immunoglobulin (IVIG), 10% solution for infusion in people with Primary Immune Thrombocytopenia, run by Biopharma Plasma LLC at 12 sites in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Primary Immune Thrombocytopenia
What is being tested?
Intravenous immunoglobulin (IVIG), 10% solution for infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
12 sitesUkraine
Study dates
26 Jul 2022to 14 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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);
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  • 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;

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Ukraine12 sites

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

    Dnipro, 49102

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

    Khmelnytskyi, 29010

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

    Kropyvnytskyi, 25030

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

    Kyiv, 02091

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

    Kyiv, 04107

  • 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

  • "Arensia Exploratory Medicine" Limited Liability Company Medical Center

    Kyiv, 08112

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

    Lviv, 79044

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

    Rivne, 33007

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

    Sumy, 40031

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

    Ternopil, 46002

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

    Uzhhorod, 88000

Other trials in Ukraine

About this study

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)

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.

Read the 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.

Being tested
Intravenous immunoglobulin (IVIG), 10% solution for infusion
Keywords
IVIG, ITP, immunomodulatory therapy, intravenous immunoglobulin, chronic primary immune thrombocytopenia
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous immunoglobulin (IVIG), 10% solution for infusionDrug

    Also called Bioven, 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.

Study groups in NCT05422365
Study groupRoleWhat they receive
Main GroupExperimentalPatients 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.
Receives: Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days after first administration of the study drug

Secondary outcomes (8)

  1. Part (Percent) of Patients With Complete Response (CR)

    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%

    Measured: 28 days after first administration of the study drug

  2. Part (Percent) of Patients With no Response (NR)

    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

    Measured: 28 days after first administration of the study drug

  3. Part (Percent) of Patients With Loss of Response (R)

    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.

    Measured: 28 days after first administration of the study drug

  4. Part (Percent) of Patients With Loss of Complete Response (CR)

    decreased platelet count <100 x 109/L or development of bleeding

    Measured: 28 days after first administration of the study drug

  5. Time (in Days) From Treatment Start to Response (R)

    Time calculated from first infusion (treatment start) to the day when the response (R) criteria are achieved

    Measured: 28 days after first administration of the study drug

  6. Time (in Days) From Treatment to Complete Response (CR)

    Time calculated from first infusion (treatment start) to the day when the complete response (CR) criteria are achieved

    Measured: 28 days after first administration of the study drug

  7. Duration (in Days) of Response (R)

    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

    Measured: 28 days after first administration of the study drug

  8. Duration (in Days) of Complete Response (CR)

    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

    Measured: 28 days after first administration of the study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start26 Jul 2022
  3. Primary completion14 Dec 2023
  4. Study completion14 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open, multicenter, international, uncontrolled
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422365
Sponsor's protocol ID
2021-BV-ITP-BP
Status last verified
Apr 2024
First submitted
14 Jun 2022
Last updated
23 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results will be published after trial completion. Access to parts of the Clinical Study Report (CSR) planned after the release of scientific publications. Individual participant data (IPD) with the code of each patient will be available In CSR

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous immunoglobulin (IVIG), 10% solution for infusion in people with Primary Immune Thrombocytopenia, run by Biopharma Plasma LLC at 12 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part (Percent) of Patients With Response (R) (time frame: 28 days after first administration of the study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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