An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• Given written informed consent

• Male or female aged ≥ 19

• Primary immune thrombocytopenia (ITP)

• Platelet <20x10^9 /L

• 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 have participate in other interventional study within 30 days

• Inability in written/verbal communication

• Engaged with an elective surgery

• Pregnant or breast-feeding women

• Women of childbearing potential who do not agree with contraception during this study

• Patients who had experienced any hypersensitivity or shock with study drug or active ingredient

• Refractory to immunoglobulin therapy

• Secondary immune thrombocytopenia

• HIV-associated ITP

• Lupus-associated ITP

• Lymphproliferative disease

• Hepatitis virus carrier

• Other disease- or infection-associated ITP

• Drug-Induced ITP

• Hereditary thrombopenia (e.g., MYH9 disorders)

• Hemolytic anemia (Positive direct Coomb's test)

• Clinically significant abnormalities of immunoglobulin

• Immunoglobulin A Deficiency

• Immune disorders or deficiency

• Alcohol or drug abuse within 6 months

• Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry

• Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month

• Patients who had undergone a splenectomy within 2 months

• Clinically significant underlying disease or medical history at investigator's discretion