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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02063789
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : May 25, 2016
Information provided by (Responsible Party):
Green Cross Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Human immunoglobulin intravenous Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP).
Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Human immunoglobulin intravenous
Human immunoglobulin intravenous; GC5107A (IV-Globulin SN Inj. 10%); Day 1: GC5107A, 1g/kg, intravenous Day 2: GC5107A, 1g/kg, intravenous; Starting infusion rate: 0.01mg/kg/min (1mg/kg/min) for first 15 minutes, and then 2-fold increase every 30 minutes by maximum 0.08ml/kg/min (8mg/kg/min). Dosing modification is allowed due to tolerance.
Drug: Human immunoglobulin intravenous
After GC5107A Intravenous injection, evaluate platelet increase
Other Name: GC5107A (IV-Globulin SN Inj. 10%)

Primary Outcome Measures :
  1. % of patients who achieved the platelet count ≥ 50 x 10^9/L increase [ Time Frame: within 7 days after intervention ]

Secondary Outcome Measures :
  1. Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss [ Time Frame: 4 weeks after intervention ]
  2. % patient with response [ Time Frame: 4 weeks after intervention ]
    Response (R): platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.

  3. % patient with complete response [ Time Frame: 4 weeks after intervention ]
    Complete response (CR): platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.

  4. Duration of response [ Time Frame: 4 weeks after intervention ]
    measured from the achievement of R to loss of R

  5. Duration of complete response [ Time Frame: 4 weeks after intervention ]
    measured from the achievement of CR to loss of CR

  6. % patient with no response [ Time Frame: 4 weeks after intervention ]
    No response (NR): platelet count < 30 x 10^9/l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding.

  7. Descriptive statistics of platelet count at each visit [ Time Frame: 4 weeks after intervention ]
  8. Haemorrhage severity rate at each visit [ Time Frame: 4 weeks after intervention ]
    Haemorrhage severity score (HSS) system

  9. Quality of Life (EQ-5D) [ Time Frame: 4 weeks after intevention ]
  10. Patient reported bleeding events [ Time Frame: 12 weeks after intervention ]
  11. Usage of rescue mediations [ Time Frame: 4 weeks after intervention ]
    Rescue medications: Acetaminophen, antihistamines.

  12. Adverse events [ Time Frame: 12 weeks after intervention ]
  13. Drug compliance [ Time Frame: 2 days of intervention ]
  14. Viral safety [ Time Frame: Base line, 4 weeks and 12 weeks after intervention ]
  15. Time to the achievement of platelet count ≥50x10^9/L increase [ Time Frame: within 7 days after intervention ]

Other Outcome Measures:
  1. Pharmacokinetics of GC5107A [ Time Frame: 12 weeks after intervention ]
    Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 immunosuppressive medications should maintain their stable doses before and during this study

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 active ingredient
  • 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 for at least 2 days prior study entry
  • Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
  • Patients who had undergone a splenectomy within 2 months
  • Clinically significant underlying disease or medical history at investigator's discretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02063789

Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Daegu Catholic University Medical Center
Deagu, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
CHA Budang Medical Center
Seoul, Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Soon Chung Hyang University Hospital
Seoul, Korea, Republic of
VHS Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Principal Investigator: Doyeun Oh, M.D., Ph.D. CHA Bundang Medical Center
Study Director: Chang-Hee Lee, M.D Green Cross Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Green Cross Corporation Identifier: NCT02063789     History of Changes
Other Study ID Numbers: GC5107A_P3
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Keywords provided by Green Cross Corporation:
Immune Thrombocytopenia
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Human Immunoglobulin
IV-Globulin SN Inj.

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs