CompletedNCT05422365Updated Sep 23, 2024Results posted

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

A Phase 3 interventional study of Intravenous immunoglobulin (IVIG), 10% solution for infusion in Primary Immune Thrombocytopenia, sponsored by Biopharma Plasma LLC. Completed at 12 sites in Ukraine. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Biopharma Plasma LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 32
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

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.

Conditions studied

Primary Immune Thrombocytopenia

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Keywords

IVIG
ITP
immunomodulatory therapy
intravenous immunoglobulin
chronic primary immune thrombocytopenia

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's enrollment of 32 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Biopharma Plasma LLC is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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;

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

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

Interventions

DrugIntravenous 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.
Also known as: Bioven, 10% solution for infusion

What researchers measure

Primary outcomes

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
Time frame: 28 days after first administration of the study drug

Secondary outcomes

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%
Time frame: 28 days after first administration of the study drug
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
Time frame: 28 days after first administration of the study drug
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.
Time frame: 28 days after first administration of the study drug
Part (Percent) of Patients With Loss of Complete Response (CR)
decreased platelet count \<100 x 109/L or development of bleeding
Time frame: 28 days after first administration of the study drug
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
Time frame: 28 days after first administration of the study drug
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
Time frame: 28 days after first administration of the study drug
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
Time frame: 28 days after first administration of the study drug
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
Time frame: 28 days after first administration of the study drug

Other outcomes

Frequency (Percent) of Adverse Events
Part of the drug administration cases with adverse events, from all cases of study drug administration
Time frame: 28 days after first administration of the study drug
Frequency of Serious Adverse Events
Part of the drug administration cases with serious adverse events, from all cases of study drug administration
Time frame: 28 days after first administration of the study drug

Results

Posted Sep 23, 2024

Participant flow

Participant flow — Overall Study
Milestone	Main Group
Started	32
Completed	32
Not completed	0

Outcome measures

PrimaryPart (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Count of participants · Participants

Part (Percent) of Patients With Response (R)
Participants	Main Group
Part (Percent) of Patients With Response (R)	24

SecondaryPart (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%

Time frame:: 28 days after first administration of the study drug
Reported as:: Number · percentage of participants

Part (Percent) of Patients With Complete Response (CR)
percentage of participants	Main Group
Part (Percent) of Patients With Complete Response (CR)	40.63 (23.61 to 57.64)

SecondaryPart (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Number · percentage of participants

Part (Percent) of Patients With no Response (NR)
percentage of participants	Main Group
Part (Percent) of Patients With no Response (NR)	25 (9.99 to 40)

SecondaryPart (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.

Time frame:: 28 days after first administration of the study drug
Reported as:: Number · percentage of participants

Part (Percent) of Patients With Loss of Response (R)
percentage of participants	Main Group
Part (Percent) of Patients With Loss of Response (R)	31.25 (15.19 to 47.31)

SecondaryPart (Percent) of Patients With Loss of Complete Response (CR)

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

Time frame:: 28 days after first administration of the study drug
Reported as:: Count of participants · Participants

Part (Percent) of Patients With Loss of Complete Response (CR)
Participants	Main Group
Part (Percent) of Patients With Loss of Complete Response (CR)	13

SecondaryTime (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Median · days

Time (in Days) From Treatment Start to Response (R)
days	Main Group
Time (in Days) From Treatment Start to Response (R)	2 (2 to 3)

SecondaryTime (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Median · days

Time (in Days) From Treatment to Complete Response (CR)
days	Main Group
Time (in Days) From Treatment to Complete Response (CR)	2 (2 to 4)

SecondaryDuration (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Median · days

Duration (in Days) of Response (R)
days	Main Group
Duration (in Days) of Response (R)	27 (25 to 29)

SecondaryDuration (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

Time frame:: 28 days after first administration of the study drug
Reported as:: Median · days

Duration (in Days) of Complete Response (CR)
days	Main Group
Duration (in Days) of Complete Response (CR)	19 (13 to 25)

Other pre-specifiedFrequency (Percent) of Adverse Events

Part of the drug administration cases with adverse events, from all cases of study drug administration

Time frame:: 28 days after first administration of the study drug
Reported as:: Count of participants · Participants

Frequency (Percent) of Adverse Events
Participants	Main Group
Frequency (Percent) of Adverse Events	4

Other pre-specifiedFrequency of Serious Adverse Events

Part of the drug administration cases with serious adverse events, from all cases of study drug administration

Time frame:: 28 days after first administration of the study drug
Reported as:: Count of participants · Participants

Frequency of Serious Adverse Events
Participants	Main Group
Frequency of Serious Adverse Events	1

Adverse events

Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Main Group	0/32 (0%)	1/32 (3.1%)	4/32 (12.5%)

Most frequent serious events

Most frequent serious events
Event	Main Group
Vein thrombosisBlood and lymphatic system disorders	1/32

Most frequent other events

Most frequent other events
Event	Main Group
HeadacheNervous system disorders	3/32
Allergic reactionGeneral disorders	1/32

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Main Group
<=18 years	0
Between 18 and 65 years	32
>=65 years	0

Age, Continuous
Age, Continuous(years)	Main Group
Median	41 (18 to 71)

Sex: Female, Male
Sex: Female, Male(Participants)	Main Group
Female	25
Male	7

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Main Group

Region of Enrollment
Region of Enrollment(participants)	Main Group
Ukraine	26
Turkey	6

Study locations

12 sites

Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council
Dnipro, 49102, Ukraine
Municipal non-profit enterprise "Khmelnytskyi Regional Hospital" of the Khmelnytskyi Regional Council
Khmelnytskyi, 29010, Ukraine
Municipal Non-Profit Enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"
Kropyvnytskyi, 25030, Ukraine
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
Kyiv, 02091, Ukraine
Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
Kyiv, 04107, 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, 04112, Ukraine
"Arensia Exploratory Medicine" Limited Liability Company Medical Center
Kyiv, 08112, Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine"
Lviv, 79044, Ukraine
Minicipal enterprise "Rivne regional clinical hospital" of Rivne regional council
Rivne, 33007, Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Hospital"
Sumy, 40031, Ukraine
Municipal non-profit enterprise "Ternopil University Hospital" of Ternopil Regional Council
Ternopil, 46002, Ukraine
Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Hospital named after Andriy Novak" of Zakarpattia Regional Council
Uzhhorod, 88000, Ukraine

References and documents

Study documents

Protocol and statistical analysis plan · Jul 3, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05422365
Lead sponsor: Biopharma Plasma LLC
Responsible party: Sponsor
First posted: Jun 16, 2022
Start date: Jul 26, 2022
Primary completion: Dec 14, 2023
Completion: Dec 14, 2023
Results posted: Sep 23, 2024
Last update: Sep 23, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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