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

Last updated: March 29, 2021
Sponsor: SK Plasma Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Dysfunctional Uterine Bleeding

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombosis

Treatment

N/A

Clinical Study ID

NCT03164915
IVIg_ITP_III_2016
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of ITP
  • Mean screening platelet count of <30×10^9/L from 3 qualifying platelet countsperformed within 14 days before the start of treatment, with no individual plateletcount 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

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 administrationof LIV-GAMMA SN Inj.
  • Administration of other investigational product 1 month before the firstadministration of LIV-GAMMA SN Inj.
  • Administration of Rituximab 3 months before the first administration of LIV-GAMMA SNInj.
  • 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 Design

Total Participants: 37
Study Start date:
October 24, 2016
Estimated Completion Date:
September 28, 2018

Connect with a study center

  • Busan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Bundang Seoul National University Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yangsan Busan National University Hospital

    Yangsan,
    Korea, Republic of

    Site Not Available

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