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A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

Primary Purpose

Immune Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LIV-GAMMA SN Inj.10%
Sponsored by
SK Plasma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dong-A University Hospital
  • Kosin University Gospel Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Chungnam National University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • The Catholic University of Korea, Seoul ST. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LIV-GAMMA SN Inj.10%

Arm Description

Outcomes

Primary Outcome Measures

Responder rate (CR or R)
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 Outcome Measures

The percentage of subjects with complete response (CR)
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
The percentage of subjects with response (R)
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
The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved
Duration of response
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
Bleeding
Bleeding assessment with ITP-BAT bleeding grading system
Adverse events

Full Information

First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
SK Plasma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05566990
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Plasma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LIV-GAMMA SN Inj.10%
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
LIV-GAMMA SN Inj.10%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder rate (CR or R)
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
The percentage of subjects with complete response (CR)
Description
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
Time Frame
28 days
Title
The percentage of subjects with response (R)
Description
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 Frame
28 days
Title
Time to response
Description
The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved
Time Frame
28 days
Title
Duration of response
Description
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
Time Frame
28 days
Title
Bleeding
Description
Bleeding assessment with ITP-BAT bleeding grading system
Time Frame
28 days
Title
Adverse events
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Wook Lee, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

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