Immune Thrombocytopenia
Conditions
Keywords
Immune Thrombocytopenia, Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Human Immunoglobulin, ITP, IVIg, IgIV, IV-Globulin SN Inj.
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.
Interventions
DRUGHuman immunoglobulin intravenous
After GC5107A Intravenous injection, evaluate platelet increase
Sponsors
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients who achieved the platelet count ≥ 50 x 10^9/L increase | within 7 days after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Quality of Life (EQ-5D) | 4 weeks after intevention | — |
| Patient reported bleeding events | 12 weeks after intervention | — |
| Usage of rescue mediations | 4 weeks after intervention | Rescue medications: Acetaminophen, antihistamines. |
| Adverse events | 12 weeks after intervention | — |
| Drug compliance | 2 days of intervention | — |
| Viral safety | Base line, 4 weeks and 12 weeks after intervention | — |
| Time to the achievement of platelet count ≥50x10^9/L increase | within 7 days after intervention | — |
| Haemorrhage severity rate at each visit | 4 weeks after intervention | Haemorrhage severity score (HSS) system |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of GC5107A | 12 weeks after intervention | Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85 |
Countries
South Korea
Outcome results
None listed