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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
After GC5107A Intravenous injection, evaluate platelet increase
Chungnam National University Hospital
Daejeon, South Korea
Daegu Catholic University Medical Center
Deagu, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
% of patients who achieved the platelet count ≥ 50 x 10^9/L increase
Time frame: within 7 days after intervention
Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss
Time frame: 4 weeks after intervention
% patient with response
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.
Time frame: 4 weeks after intervention
% patient with complete response
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.
Time frame: 4 weeks after intervention
Duration of response
measured from the achievement of R to loss of R
Time frame: 4 weeks after intervention
Duration of complete response
measured from the achievement of CR to loss of CR
Time frame: 4 weeks after intervention
% patient with no response
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.
Time frame: 4 weeks after intervention
Descriptive statistics of platelet count at each visit
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Gachon University Gil Medical Center
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
CHA Budang Medical Center
Seoul, South Korea
Ewha Womans University Medical Center
Seoul, South Korea
...and 4 more locations
Time frame: 4 weeks after intervention
Haemorrhage severity rate at each visit
Haemorrhage severity score (HSS) system
Time frame: 4 weeks after intervention
Quality of Life (EQ-5D)
Time frame: 4 weeks after intevention
Patient reported bleeding events
Time frame: 12 weeks after intervention
Usage of rescue mediations
Rescue medications: Acetaminophen, antihistamines.
Time frame: 4 weeks after intervention
Adverse events
Time frame: 12 weeks after intervention
Drug compliance
Time frame: 2 days of intervention
Viral safety
Time frame: Base line, 4 weeks and 12 weeks after intervention
Time to the achievement of platelet count ≥50x10^9/L increase
Time frame: within 7 days after intervention