An Open Phase 3 study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001026
- Lead Sponsor
- Green Cross
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 70
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 status
-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
1. HIV-associated ITP
2. Lupus-associated ITP
3. Lymphoproliferative disease
4. Hepatitis virus carrier
5. Other disease-or infection-associated ITP
-Drug-Induced ITP
-Hereditary thrombopenia(eg.MYH9 disorder)
-Hemolytic anemia(Positive direct Comb's test)
-Clinically significant abnormallities 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 agetns within 1 month
-Patients who had undergone a splenectomy within 2 months
-Clinically significant underlying disease or medical history at investirator's discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of subjects with an increase in platelet count to =50x10^9/L within 7 days
- Secondary Outcome Measures
Name Time Method Time to the achievement of platelet count 50x10^9/L increase;Duration from the achievement of platelet count =50x10^9/L increase to the loss;% patient with response;% patient with complete response;Duration of response;Duration of complete response;%patient with no response;Platelet counts at each visit;Platelet counts;Haemorrhage severity rating scale and character of hemorrhage;Evaluation of quality of life by EQ-5D;Virus safety ;Clinical pharmacodynamics