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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency (Percent) of Adverse Events | Part of the drug administration cases with adverse events, from all cases of study drug administration | 28 days after first administration of the study drug |
| Frequency of Serious Adverse Events |
Inclusion criteria:
Exclusion criteria:
Criteria for exclusion of subjects (discontinuation of treatment with the study drug):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal non-profit enterprise "City Clinical Hospital No. 4" of the Dnipro City Council | Dnipro | 49102 | Ukraine | |||
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| Label | URL |
|---|---|
| Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), rev. 4, 16 December 2021 | View source |
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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
After the scientific publication of trial results, 3 months later
For specialists in field medicine, pharmacy, scientists
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2023 |
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Open, multicenter, international, uncontrolled
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|
| 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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
| 28 days after first administration of the study drug |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 28 days after first administration of the study drug |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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% | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | Part (Percent) of Patients With Loss of Complete Response (CR) | decreased platelet count <100 x 109/L or development of bleeding | Posted | Count of Participants | Participants | 28 days after first administration of the study drug |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | 95% Confidence Interval | days | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | 95% Confidence Interval | days | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | 95% Confidence Interval | days | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | 95% Confidence Interval | days | 28 days after first administration of the study drug |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Frequency (Percent) of Adverse Events | Part of the drug administration cases with adverse events, from all cases of study drug administration | Posted | Count of Participants | Participants | 28 days after first administration of the study drug |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Frequency of Serious Adverse Events | Part of the drug administration cases with serious adverse events, from all cases of study drug administration | Posted | Count of Participants | Participants | 28 days after first administration of the study drug |
|
|
28 days
Definitions of adverse events is similar to clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 32 | 1 | 32 | 4 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vein thrombosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Thrombosis of superficial vein of right leg |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Allergic reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Igor Rudenko, Clinical Research Physician | Biopharma Plasma LLC | +380503300865 | i.rudenko@biopharma.ua |
| Apr 24, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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