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

Immune Thrombocytopenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164915
• Other study ID #: IVIg_ITP_III_2016
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2016
• Est. completion date: September 28, 2018

Study information

• Verified date: March 2021
• Source: SK Plasma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 28, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Biological:
• LIV-GAMMA SN Inj.

Locations

Country	Name	City	State
Korea, Republic of	Busan National University Hospital	Busan
Korea, Republic of	Bundang Seoul National University Hospital	Seongnam
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Yangsan Busan National University Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
SK Plasma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	Time to Response	The time from the start of treatment to the time of achievement of CR or R	28 days
Secondary	Duration of response	the time from the achievement of CR or R to loss of CR or R	28 days
Secondary	Bleeding	Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)	28 days