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

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

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.

Study Overview

• Status: Completed
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Biological: LIV-GAMMA SN Inj.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Busan National University Hospital
  • Seongnam, Korea, Republic of
    • Bundang Seoul National University Hospital
  • Seoul, 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
  • Yangsan, Korea, Republic of
    • Yangsan Busan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIV-GAMMA SN Inj.	Biological: LIV-GAMMA SN Inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SK Plasma Co., Ltd.
• Investigators: Study Chair: Jong Wook Lee, MD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Actual): April 3, 2018
• Study Completion (Actual): September 28, 2018

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: IVIg_ITP_III_2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No