An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia
Last updated on April 2022Recruitment
- 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