Clinical trial NCT05566990: A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)
Official title: A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Lead sponsor: SK Plasma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Responder rate (CR or R)
timeFrame: 28 days
Secondary outcomes:
measure: The percentage of subjects with complete response (CR)
timeFrame: 28 days
measure: The percentage of subjects with response (R)
timeFrame: 28 days
measure: Time to response
timeFrame: 28 days
measure: Duration of response
timeFrame: 28 days
measure: Bleeding
timeFrame: 28 days
measure: Adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jong Wook Lee, MD
role: STUDY_CHAIR
References: