A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

NCT05566990 | Completed Phase 3

• 1 other identifier: IVIg10%_ITP_III_2019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (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 time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Responder rate (CR or R)

  The rate of subjects with complete response (CR) defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding or response (R) defined as cases with a platelet count ≥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 with an absence of bleeding

  28 days

Secondary Outcomes (6)

• 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.10%

EXPERIMENTAL

Biological: LIV-GAMMA SN Inj.10%

Interventions

LIV-GAMMA SN Inj.10% BIOLOGICAL

LIV-GAMMA SN Inj. 10% is administered intravenously at a dose of 1 g/kg daily for 2 consecutive days to patients with primary immune thrombocytopenia.

LIV-GAMMA SN Inj.10%

Eligibility Criteria

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

You may qualify if:

• Completed informed consent process
• Male or female aged ≥19 years
• Diagnosis of chronic ITP (≥12 months since diagnosis)
• 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
• If the patient is taking corticosteroid, attenuated androgen, cyclophosphamide, azathioprine or other drugs for ITP, the treatment regimen and dose should be stable at least 1 month prior to screening and should be lasted during this study
• Females of child-bearing potential with a negative urine pregnancy test and who agree with contraception during this study

You may not qualify if:

• Patients who have allergy or hypersensitivity to blood products, blood-derived products, intravenous immunoglobulin (IVIg) or immunoglobulin G (IgG)
• Patients who have immunoglobulin A (IgA) deficiency
• Patients who were immunized with live attenuated vaccines within 12 months from the first administration of LIV-GAMMA SN Inj.10%
• Patients who had received IVIg or blood/blood-derived products within 1 month from the first administration of LIV-GAMMA SN Inj.10%
• Patients who had received other investigational products within 1 month from the first administration of LIV-GAMMA SN Inj.10%
• Patients who had received Rituximab within 3 months from the first administration of LIV-GAMMA SN Inj.10%
• Patients who were taking anticoagulants or other agents related to platelet function (e.g., Aspirin, other NSAID) at the time of screening
• Patients who are pregnant and nursing
• Patients who are positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at the time of screening
• Patients who have 3-fold higher levels of alanine transaminase (ALT), aspartate transaminase (AST) than the upper limit of normal at the time of screening
• Patients who suffered from severe renal impairment (eGFR\<30 mL/min/1.73 m\^2 at the time of screening)
• Patients who had history of deep vein thrombosis (DVT) or thrombotic complications against IVIg therapy
• Patients who had history of neurovascular or cardiovascular disorders (e.g., Blood hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolism, unstable angina)
• Patients who have an ongoing history of acute or chronic condition that affect to the participation of this study
• Patients who have an ongoing history of medical condition inducing secondary immune deficiency (e.g., Leukemia, lymphoma, multiple myeloma, HIV infection, chronic or cyclic neutropenia (absolute neutrophil count\<500/mm\^3)

Sponsors & Collaborators

• SK Plasma Co., Ltd.: lead

Study Sites (11)

Dong-A University Hospital

Busan, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

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

Seoul, 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: September 30, 2022
• First Posted: October 5, 2022
• Study Start: July 19, 2019
• Primary Completion: June 3, 2021
• Study Completion: November 26, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-09

Locations

KR (11)