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OpenTrials
Completed

NCT Number: NCT02063789

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

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.

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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

Chungnam National University Hospital, Daejeon, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Human immunoglobulin intravenous

Drug

After GC5107A Intravenous injection, evaluate platelet increase

Other names: GC5107A (IV-Globulin SN Inj. 10%)

Primary outcomes

  1. % of patients who achieved the platelet count ≥ 50 x 10^9/L increase

    Time frame: within 7 days after intervention

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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).

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2014
Registry last updated
May 25, 2016

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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