Immune Thrombocytopenia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (ITP). The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10\^9/L and at least a 2-fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.
Interventions
BIOLOGICALLIV-GAMMA SN Inj.10%
LIV-GAMMA SN Inj. 10% is administered intravenously at a dose of 1 g/kg daily for 2 consecutive days to patients with primary immune thrombocytopenia.
Sponsors
SK Plasma Co., Ltd.
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
* Completed informed consent process * Male or female aged ≥19 years * Diagnosis of chronic ITP (≥12 months since diagnosis) * Mean screening platelet count of \<30×10\^9/L from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10\^9/L * No other factors inducing ITP * If the patient is taking corticosteroid, attenuated androgen, cyclophosphamide, azathioprine or other drugs for ITP, the treatment regimen and dose should be stable at least 1 month prior to screening and should be lasted during this study * Females of child-bearing potential with a negative urine pregnancy test and who agree with contraception during this study
Exclusion criteria
* Patients who have allergy or hypersensitivity to blood products, blood-derived products, intravenous immunoglobulin (IVIg) or immunoglobulin G (IgG) * Patients who have immunoglobulin A (IgA) deficiency * Patients who were immunized with live attenuated vaccines within 12 months from the first administration of LIV-GAMMA SN Inj.10% * Patients who had received IVIg or blood/blood-derived products within 1 month from the first administration of LIV-GAMMA SN Inj.10% * Patients who had received other investigational products within 1 month from the first administration of LIV-GAMMA SN Inj.10% * Patients who had received Rituximab within 3 months from the first administration of LIV-GAMMA SN Inj.10% * Patients who were taking anticoagulants or other agents related to platelet function (e.g., Aspirin, other NSAID) at the time of screening * Patients who are pregnant and nursing * Patients who are positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at the time of screening * Patients who have 3-fold higher levels of alanine transaminase (ALT), aspartate transaminase (AST) than the upper limit of normal at the time of screening * Patients who suffered from severe renal impairment (eGFR\<30 mL/min/1.73 m\^2 at the time of screening) * Patients who had history of deep vein thrombosis (DVT) or thrombotic complications against IVIg therapy * Patients who had history of neurovascular or cardiovascular disorders (e.g., Blood hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolism, unstable angina) * Patients who have an ongoing history of acute or chronic condition that affect to the participation of this study * Patients who have an ongoing history of medical condition inducing secondary immune deficiency (e.g., Leukemia, lymphoma, multiple myeloma, HIV infection, chronic or cyclic neutropenia (absolute neutrophil count\<500/mm\^3) * Patients who are suffering from hypertension (systolic blood pressure\>160 mmHg or diastolic blood pressure\>100 mmHg) * Patients who have hemoglobin level≤10 g/dL at the time of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate (CR or R) | 28 days | The rate of subjects with complete response (CR) defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding or response (R) defined as cases with a platelet count ≥30×10\^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects with response (R) | 28 days | The percentage of subjects with response (R) defined as cases with a platelet count ≥30×10\^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding |
| Time to response | 28 days | The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved |
| The percentage of subjects with complete response (CR) | 28 days | The percentage of subjects with complete response (CR) defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding |
| Bleeding | 28 days | Bleeding assessment with ITP-BAT bleeding grading system |
| Adverse events | 28 days | — |
| Duration of response | 28 days | The time from the achievement of complete response (CR) or response (R) to the day when loss of complete response (CR) or response (R) is achieved |
Countries
South Korea
Outcome results
None listed