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

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Immune Thrombocytopenia

Treatments: Drug: Human immunoglobulin intravenous

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063789

GC5107A_P3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Human immunoglobulin intravenous

Experimental group

Description:

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.

Treatment:

Drug: Human immunoglobulin intravenous