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Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.
GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human immunoglobulin intravenous | Experimental | Human immunoglobulin intravenous; GC5107A (IV-Globulin SN Inj. 10%); Day 1: GC5107A, 1g/kg, intravenous Day 2: GC5107A, 1g/kg, intravenous; Starting infusion rate: 0.01mg/kg/min (1mg/kg/min) for first 15 minutes, and then 2-fold increase every 30 minutes by maximum 0.08ml/kg/min (8mg/kg/min). Dosing modification is allowed due to tolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human immunoglobulin intravenous | Drug | After GC5107A Intravenous injection, evaluate platelet increase |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients who achieved the platelet count ≥ 50 x 10^9/L increase | within 7 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss | 4 weeks after intervention | |
| % patient with response | Response (R): platelet count ≥ 30 x 10^9/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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of GC5107A | Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85 | 12 weeks after intervention |
Inclusion Criteria:
Exclusion Criteria:
Patients who have participate in other interventional study within 30 days
Inability in written/verbal communication
Engaged with an elective surgery
Pregnant or breast-feeding women
Women of childbearing potential who do not agree with contraception during this study
Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Refractory to immunoglobulin therapy
Secondary immune thrombocytopenia
Drug-Induced ITP
Hereditary thrombopenia (e.g., MYH9 disorders)
Hemolytic anemia (Positive direct Coomb's test)
Clinically significant abnormalities of immunoglobulin
Immunoglobulin A Deficiency
Immune disorders or deficiency
Alcohol or drug abuse within 6 months
Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
Patients who had undergone a splenectomy within 2 months
Clinically significant underlying disease or medical history at investigator's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Doyeun Oh, M.D., Ph.D. | CHA Bundang Medical Center | Principal Investigator |
| Chang-Hee Lee, M.D | Green Cross Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea | ||||
| Daegu Catholic University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29736158 | Derived | Hong J, Bang SM, Mun YC, Yhim HY, Lee J, Lim HS, Oh D; Korean GC IVIg Investigators. Efficacy and Safety of a New 10% Intravenous Immunoglobulin Product in Patients with Primary Immune Thrombocytopenia (ITP). J Korean Med Sci. 2018 Apr 24;33(19):e142. doi: 10.3346/jkms.2018.33.e142. eCollection 2018 May 7. |
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| 4 weeks after intervention |
| % patient with complete response | Complete response (CR): platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding. | 4 weeks after intervention |
| Duration of response | measured from the achievement of R to loss of R | 4 weeks after intervention |
| Duration of complete response | measured from the achievement of CR to loss of CR | 4 weeks after intervention |
| % patient with no response | No response (NR): platelet count < 30 x 10^9/l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding. | 4 weeks after intervention |
| Descriptive statistics of platelet count at each visit | 4 weeks after intervention |
| Haemorrhage severity rate at each visit | Haemorrhage severity score (HSS) system | 4 weeks after intervention |
| Quality of Life (EQ-5D) | 4 weeks after intevention |
| Patient reported bleeding events | 12 weeks after intervention |
| Usage of rescue mediations | Rescue medications: Acetaminophen, antihistamines. | 4 weeks after intervention |
| Adverse events | 12 weeks after intervention |
| Drug compliance | 2 days of intervention |
| Viral safety | Base line, 4 weeks and 12 weeks after intervention |
| Time to the achievement of platelet count ≥50x10^9/L increase | within 7 days after intervention |
| Deagu |
| South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| CHA Budang Medical Center | Seoul | South Korea |
| Ewha Womans University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Soon Chung Hyang University Hospital | Seoul | South Korea |
| VHS Medical Center | Seoul | South Korea |
| 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 |
| 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 |
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