An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP).

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Human immunoglobulin intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Given written informed consent Male or female aged ≥ 19 Primary immune thrombocytopenia (ITP) Platelet <20x10^9 /L Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study 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 HIV-associated ITP Lupus-associated ITP Lymphproliferative disease Hepatitis virus carrier Other disease- or infection-associated ITP 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human immunoglobulin intravenous<br>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. | Drug: Human immunoglobulin intravenous<br>* After GC5107A Intravenous injection, evaluate platelet increase<br>* Other names: GC5107A (IV-Globulin SN Inj. 10%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients who achieved the platelet count ≥ 50 x 10^9/L increase |  | within 7 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Thrombocytopenia, Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Human Immunoglobulin, IVIg, IgIV, IV-Globulin SN Inj., ITP