An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia
- Conditions
- Immune Thrombocytopenia
- Interventions
- Drug: Human immunoglobulin intravenous
- Registration Number
- NCT02063789
- Lead Sponsor
- Green Cross Corporation
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Human immunoglobulin intravenous Human immunoglobulin intravenous Human immunoglobulin intravenous; GC5107A (IV-Globulin SN Inj. 10%); Day 1: GC5107A, 1g/kg, intravenous Day 2: GC5107A, 1g/kg, intravenous; Starting infusion rate: 0.01mg/kg/min (1mg/kg/min) for first 15 minutes, and then 2-fold increase every 30 minutes by maximum 0.08ml/kg/min (8mg/kg/min). Dosing modification is allowed due to tolerance.
- Primary Outcome Measures
Name Time Method % of patients who achieved the platelet count ≥ 50 x 10^9/L increase within 7 days after intervention
- Secondary Outcome Measures
Name Time Method Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss 4 weeks after intervention % patient with response 4 weeks after intervention Response (R): platelet count ≥ 30 x 10\^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
% patient with complete response 4 weeks after intervention Complete response (CR): platelet count \>100 x 10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
Duration of response 4 weeks after intervention measured from the achievement of R to loss of R
Duration of complete response 4 weeks after intervention measured from the achievement of CR to loss of CR
% patient with no response 4 weeks after intervention No response (NR): platelet count \< 30 x 10\^9/l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding.
Descriptive statistics of platelet count at each visit 4 weeks after intervention Haemorrhage severity rate at each visit 4 weeks after intervention Haemorrhage severity score (HSS) system
Adverse events 12 weeks after intervention Viral safety Base line, 4 weeks and 12 weeks after intervention Quality of Life (EQ-5D) 4 weeks after intevention Patient reported bleeding events 12 weeks after intervention Drug compliance 2 days of intervention Usage of rescue mediations 4 weeks after intervention Rescue medications: Acetaminophen, antihistamines.
Time to the achievement of platelet count ≥50x10^9/L increase within 7 days after intervention
Trial Locations
- Locations (14)
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Deagu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
CHA Budang Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Soon Chung Hyang University Hospital
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of