Back to resultsA Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. 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.
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ITP
- 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
- Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study.
Exclusion Criteria:
- Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G
- Immunoglobulin A (IgA) deficiency
- Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj.
- Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj.
- Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj.
- Treatment with anti-coagulants, which may affect the function of platelet
- Positive HIV, HBV, HCV
- 3-fold increase of ALT or AST compared to normal upper limit
- eCFR < 30mL/min/1.73m^2
- History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances
- Hemoglobin > 10g/dL
Sites / Locations
- Busan National University Hospital
- Bundang Seoul National University Hospital
- Samsung Medical Center
- Severance Hospital
- The Catholic University of Korea, Seoul ST. Mary's Hospital
- Yangsan Busan National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LIV-GAMMA SN Inj.
Arm Description
Outcomes
Primary Outcome Measures
Responder rate (CR or R)
The rate of subjects with complete response defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥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 without bleeding
Secondary Outcome Measures
The percentage of subjects with complete response (CR)
The percentage of subjects with CR defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
The percentage of subjects with response (R)
The percentage of subjects with R defined as cases with a platelet count of ≥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 without bleeding
Time to Response
The time from the start of treatment to the time of achievement of CR or R
Duration of response
the time from the achievement of CR or R to loss of CR or R
Bleeding
Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03164915
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. 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. in Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
September 28, 2018 (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 main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with 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 duration of response, and the safety of LIV-GAMMA SN Inj.
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
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIV-GAMMA SN Inj.
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
LIV-GAMMA SN Inj.
Primary Outcome Measure Information:
Title
Responder rate (CR or R)
Description
The rate of subjects with complete response defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥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 without bleeding
Time Frame
28 days
Secondary Outcome Measure Information:
Title
The percentage of subjects with complete response (CR)
Description
The percentage of subjects with CR defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
Time Frame
28 days
Title
The percentage of subjects with response (R)
Description
The percentage of subjects with R defined as cases with a platelet count of ≥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 without bleeding
Time Frame
28 days
Title
Time to Response
Description
The time from the start of treatment to the time of achievement of CR or R
Time Frame
28 days
Title
Duration of response
Description
the time from the achievement of CR or R to loss of CR or R
Time Frame
28 days
Title
Bleeding
Description
Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ITP
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
Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study.
Exclusion Criteria:
Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G
Immunoglobulin A (IgA) deficiency
Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj.
Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj.
Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj.
Treatment with anti-coagulants, which may affect the function of platelet
Positive HIV, HBV, HCV
3-fold increase of ALT or AST compared to normal upper limit
eCFR < 30mL/min/1.73m^2
History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances
Hemoglobin > 10g/dL
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
Busan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Bundang Seoul National University Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
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
Facility Name
Yangsan Busan National University Hospital
City
Yangsan
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. in Primary Immune Thrombocytopenia (ITP)
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