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

NCT03164915 | Completed Phase 3

• 1 other identifier: IVIg_ITP_III_2016
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The percentage of subjects with complete response (CR)

  28 days

• The percentage of subjects with response (R)

  28 days

• Time to Response

  28 days

• Duration of response

  28 days

• Bleeding

  28 days

Study Arms (1)

LIV-GAMMA SN Inj.

EXPERIMENTAL

Biological: LIV-GAMMA SN Inj.

Interventions

LIV-GAMMA SN Inj. BIOLOGICAL

LIV-GAMMA SN Inj.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• SK Plasma Co., Ltd.: lead

Study Sites (6)

Busan National University Hospital

Busan, South Korea

Location

Bundang Seoul National University Hospital

Seongnam, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Yangsan Busan National University Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jong Wook Lee, MD

  The Catholic University of Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: October 24, 2016
• Primary Completion: April 3, 2018
• Study Completion: September 28, 2018
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

KR (6)