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

NCT ID: NCT03164915

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-24
• Study Completion Date: 2018-09-28

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIV-GAMMA SN Inj.

Group Type: EXPERIMENTAL

LIV-GAMMA SN Inj.

Intervention Type: BIOLOGICAL

Interventions

LIV-GAMMA SN Inj.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Plasma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong Wook Lee, MD

Role: STUDY_CHAIR

The Catholic University of Korea

Locations

Busan National University Hospital

Busan, , South Korea

Bundang Seoul National University Hospital

Seongnam, , South Korea

Samsung Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, , South Korea

Yangsan Busan National University Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

IVIg_ITP_III_2016

Identifier Type: -

Identifier Source: org_study_id