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

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).

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.

Study Overview

• Status: Completed
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Drug: Human immunoglobulin intravenous

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
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital
  • Deagu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Hwasun, Korea, Republic of
    • Chonnam National University Hwasun Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Medical Center
  • Seoul, Korea, Republic of
    • VHS Medical Center
  • Seoul, Korea, Republic of
    • CHA Budang Medical Center
  • Seoul, Korea, Republic of
    • Soon Chung Hyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: GC5107A (IV-Globulin SN Inj. 10%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% of patients who achieved the platelet count ≥ 50 x 10^9/L increase	within 7 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss		4 weeks after intervention
% patient with response	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.	4 weeks after intervention
% patient with complete response	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 weeks after intervention
Duration of response	measured from the achievement of R to loss of R	4 weeks after intervention
Duration of complete response	measured from the achievement of CR to loss of CR	4 weeks after intervention
% patient with no response	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.	4 weeks after intervention
Descriptive statistics of platelet count at each visit		4 weeks after intervention
Haemorrhage severity rate at each visit	Haemorrhage severity score (HSS) system	4 weeks after intervention
Quality of Life (EQ-5D)		4 weeks after intevention
Patient reported bleeding events		12 weeks after intervention
Usage of rescue mediations	Rescue medications: Acetaminophen, antihistamines.	4 weeks after intervention
Adverse events		12 weeks after intervention
Drug compliance		2 days of intervention
Viral safety		Base line, 4 weeks and 12 weeks after intervention
Time to the achievement of platelet count ≥50x10^9/L increase		within 7 days after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of GC5107A	Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85	12 weeks after intervention

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Doyeun Oh, M.D., Ph.D., CHA Bundang Medical Center; Study Director: Chang-Hee Lee, M.D, Green Cross Corporation

Publications and helpful links

General Publications

• Hong J, Bang SM, Mun YC, Yhim HY, Lee J, Lim HS, Oh D; Korean GC IVIg Investigators. Efficacy and Safety of a New 10% Intravenous Immunoglobulin Product in Patients with Primary Immune Thrombocytopenia (ITP). J Korean Med Sci. 2018 Apr 24;33(19):e142. doi: 10.3346/jkms.2018.33.e142. eCollection 2018 May 7.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Immune Thrombocytopenia; ITP; Idiopathic Thrombocytopenic Purpura; Immune Thrombocytopenic Purpura; IVIg; Human Immunoglobulin; IgIV; IV-Globulin SN Inj.
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: GC5107A_P3