Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criteria

Primary immune thrombocytopenia (ITP)
Platelet <20x10^9 /L
Given written informed consent
...
Primary immune thrombocytopenia (ITP)
Platelet <20x10^9 /L
Given written informed consent
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

Exclusion Criteria

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

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

Primary immune thrombocytopenia (ITP)
Platelet <20x10^9 /L
Given written informed consent
...
Primary immune thrombocytopenia (ITP)
Platelet <20x10^9 /L
Given written informed consent
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

Exclusion Criteria

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

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