Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criteria

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
Given written informed consent
...
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
Given written informed consent
Primary immune thrombocytopenia (ITP)
Male or female aged ≥ 19

Exclusion Criteria

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

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
Given written informed consent
...
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
Given written informed consent
Primary immune thrombocytopenia (ITP)
Male or female aged ≥ 19

Exclusion Criteria

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