Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criteria

Male or female aged ≥ 19
Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study
Platelet <20x10^9 /L
...
Male or female aged ≥ 19
Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study
Platelet <20x10^9 /L
Primary immune thrombocytopenia (ITP)
Given written informed consent

Exclusion Criteria

Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Clinically significant underlying disease or medical history at investigator's discretion
Immunoglobulin A Deficiency
...
Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Clinically significant underlying disease or medical history at investigator's discretion
Immunoglobulin A Deficiency
Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
Pregnant or breast-feeding women
HIV-associated ITP
Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Engaged with an elective surgery
Clinically significant abnormalities of immunoglobulin
Hepatitis virus carrier
Patients who have participate in other interventional study within 30 days
Lupus-associated ITP
Other disease- or infection-associated ITP
Drug-Induced ITP
Lymphproliferative disease
Inability in written/verbal communication
Hereditary thrombopenia (e.g., MYH9 disorders)
Hemolytic anemia (Positive direct Coomb's test)
Immune disorders or deficiency
Refractory to immunoglobulin therapy
Alcohol or drug abuse within 6 months
Patients who had undergone a splenectomy within 2 months
Women of childbearing potential who do not agree with contraception during this study

Summary

Conditions
Immune Thrombocytopenia
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

Description

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.

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.

Inclusion Criteria

Male or female aged ≥ 19
Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study
Platelet <20x10^9 /L
...
Male or female aged ≥ 19
Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study
Platelet <20x10^9 /L
Primary immune thrombocytopenia (ITP)
Given written informed consent

Exclusion Criteria

Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Clinically significant underlying disease or medical history at investigator's discretion
Immunoglobulin A Deficiency
...
Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Clinically significant underlying disease or medical history at investigator's discretion
Immunoglobulin A Deficiency
Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
Pregnant or breast-feeding women
HIV-associated ITP
Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Engaged with an elective surgery
Clinically significant abnormalities of immunoglobulin
Hepatitis virus carrier
Patients who have participate in other interventional study within 30 days
Lupus-associated ITP
Other disease- or infection-associated ITP
Drug-Induced ITP
Lymphproliferative disease
Inability in written/verbal communication
Hereditary thrombopenia (e.g., MYH9 disorders)
Hemolytic anemia (Positive direct Coomb's test)
Immune disorders or deficiency
Refractory to immunoglobulin therapy
Alcohol or drug abuse within 6 months
Patients who had undergone a splenectomy within 2 months
Women of childbearing potential who do not agree with contraception during this study

Tracking Information

NCT #
NCT02063789
Collaborators
Not Provided
Investigators
  • Principal Investigator: Doyeun Oh, M.D., Ph.D. CHA Bundang Medical Center Study Director: Chang-Hee Lee, M.D Green Cross Corporation
  • Doyeun Oh, M.D., Ph.D. CHA Bundang Medical Center Study Director: Chang-Hee Lee, M.D Green Cross Corporation
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