An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

Last updated: May 23, 2016
Sponsor: Green Cross Corporation
Overall Status: Completed

Phase

3

Condition

Thrombosis

Platelet Disorders

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT02063789
GC5107A_P3
  • Ages > 19
  • All Genders

Study Summary

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Given written informed consent

  • Male or female aged ≥ 19

  • Primary immune thrombocytopenia (ITP)

  • Platelet <20x10^9 /L

  • Patients who have taken adrenal cortical hormones and/or other immunosuppressivemedications should maintain their stable doses before and during this study

Exclusion

Exclusion Criteria:

  • Patients who have participate in other interventional study within 30 days

  • Inability in written/verbal communication

  • Engaged with an elective surgery

  • Pregnant or breast-feeding women

  • Women of childbearing potential who do not agree with contraception during this study

  • Patients who had experienced any hypersensitivity or shock with study drug or activeingredient

  • Refractory to immunoglobulin therapy

  • Secondary immune thrombocytopenia

  • HIV-associated ITP

  • Lupus-associated ITP

  • Lymphproliferative disease

  • Hepatitis virus carrier

  • Other disease- or infection-associated ITP

  • Drug-Induced ITP

  • Hereditary thrombopenia (e.g., MYH9 disorders)

  • Hemolytic anemia (Positive direct Coomb's test)

  • Clinically significant abnormalities of immunoglobulin

  • Immunoglobulin A Deficiency

  • Immune disorders or deficiency

  • Alcohol or drug abuse within 6 months

  • Patients who had taken any medications which may effect platelet function or count forat least 2 days prior study entry

  • Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1month

  • Patients who had undergone a splenectomy within 2 months

  • Clinically significant underlying disease or medical history at investigator'sdiscretion

Study Design

Total Participants: 81
Study Start date:
June 01, 2014
Estimated Completion Date:
April 30, 2016

Study Description

GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.

Connect with a study center

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Daegu Catholic University Medical Center

    Deagu,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • CHA Budang Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Medical Center

    Seoul,
    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

  • Soon Chung Hyang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • VHS Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

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