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

Prospective, Non-Randomized, Open-label, Single-arm, Multiple-Center PhaseIII Clinical Trial to Evaluate the Efficacy and safety of IV-Globulin SN Inj.10% in the patients diagnosed with Immune Thrombocytopenia(ITP)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001026

Enrollment

Registered

2014-03-18

Start date

2014-03-10

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental : Human immunoglobulin intravenous Human immunoglobulin intravenous: IV-Globulin SN Inj.10%: Day1: IV-Globulin SN Inj.10% 1g/kg intravenous Day2: IV-Globulin SN Inj.10% 1g/kg intr

Eligibility

Sex/Gender

All

Inclusion 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 status

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
The percentage of subjects with an increase in platelet count to =50x10^9/L within 7 days	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactBang Ju

Bundang CHA General Hospital

Outcome results