Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criteria

Male or female aged ≥ 19
Given written informed consent
Platelet <20x10^9 /L
...
Male or female aged ≥ 19
Given written informed consent
Platelet <20x10^9 /L
Primary immune thrombocytopenia (ITP)
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 had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Hemolytic anemia (Positive direct Coomb's test)
Patients who had undergone a splenectomy within 2 months
...
Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Hemolytic anemia (Positive direct Coomb's test)
Patients who had undergone a splenectomy within 2 months
Clinically significant abnormalities of immunoglobulin
Alcohol or drug abuse within 6 months
Inability in written/verbal communication
Drug-Induced ITP
HIV-associated ITP
Hepatitis virus carrier
Lupus-associated ITP
Immunoglobulin A Deficiency
Patients who have participate in other interventional study within 30 days
Hereditary thrombopenia (e.g., MYH9 disorders)
Pregnant or breast-feeding women
Clinically significant underlying disease or medical history at investigator's discretion
Women of childbearing potential who do not agree with contraception during this study
Immune disorders or deficiency
Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
Engaged with an elective surgery
Other disease- or infection-associated ITP
Lymphproliferative disease
Refractory to immunoglobulin therapy
Patients who had experienced any hypersensitivity or shock with study drug or active ingredient

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
Given written informed consent
Platelet <20x10^9 /L
...
Male or female aged ≥ 19
Given written informed consent
Platelet <20x10^9 /L
Primary immune thrombocytopenia (ITP)
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 had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Hemolytic anemia (Positive direct Coomb's test)
Patients who had undergone a splenectomy within 2 months
...
Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
Hemolytic anemia (Positive direct Coomb's test)
Patients who had undergone a splenectomy within 2 months
Clinically significant abnormalities of immunoglobulin
Alcohol or drug abuse within 6 months
Inability in written/verbal communication
Drug-Induced ITP
HIV-associated ITP
Hepatitis virus carrier
Lupus-associated ITP
Immunoglobulin A Deficiency
Patients who have participate in other interventional study within 30 days
Hereditary thrombopenia (e.g., MYH9 disorders)
Pregnant or breast-feeding women
Clinically significant underlying disease or medical history at investigator's discretion
Women of childbearing potential who do not agree with contraception during this study
Immune disorders or deficiency
Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
Engaged with an elective surgery
Other disease- or infection-associated ITP
Lymphproliferative disease
Refractory to immunoglobulin therapy
Patients who had experienced any hypersensitivity or shock with study drug or active ingredient

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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