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NCT Number: NCT03164915

A Clinical 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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Busan National University Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIV-GAMMA SN Inj.

Biological

Primary outcomes

  1. Responder rate (CR or R)

    Time frame: 28 days

    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

Secondary outcomes

  1. The percentage of subjects with complete response (CR)

    Time frame: 28 days

    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

  2. The percentage of subjects with response (R)

    Time frame: 28 days

    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

  3. Time to Response

    Time frame: 28 days

    The time from the start of treatment to the time of achievement of CR or R

  4. Duration of response

    Time frame: 28 days

    the time from the achievement of CR or R to loss of CR or R

  5. Bleeding

    Time frame: 28 days

    Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)

Sponsors and collaborators

Lead sponsor

SK Plasma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 24, 2017
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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