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

Primary Purpose

Immune Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Human immunoglobulin intravenous
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Human Immunoglobulin, ITP, IVIg, IgIV, IV-Globulin SN Inj.

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chungnam National University Hospital
  • Daegu Catholic University Medical Center
  • Chonnam National University Hwasun Hospital
  • Gachon University Gil Medical Center
  • Chonbuk National University Hospital
  • Pusan National University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • CHA Budang Medical Center
  • Ewha Womans University Medical Center
  • Samsung Medical Center
  • Severance Hospital
  • Soon Chung Hyang University Hospital
  • VHS Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human immunoglobulin intravenous

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss
% 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.
% 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.
Duration of response
measured from the achievement of R to loss of R
Duration of complete response
measured from the achievement of CR to loss of CR
% 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.
Descriptive statistics of platelet count at each visit
Haemorrhage severity rate at each visit
Haemorrhage severity score (HSS) system
Quality of Life (EQ-5D)
Patient reported bleeding events
Usage of rescue mediations
Rescue medications: Acetaminophen, antihistamines.
Adverse events
Drug compliance
Viral safety
Time to the achievement of platelet count ≥50x10^9/L increase

Full Information

First Posted
February 13, 2014
Last Updated
May 23, 2016
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02063789
Brief Title
An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Immune Thrombocytopenia, Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Human Immunoglobulin, ITP, IVIg, IgIV, IV-Globulin SN Inj.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human immunoglobulin intravenous
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Human immunoglobulin intravenous
Other Intervention Name(s)
GC5107A (IV-Globulin SN Inj. 10%)
Intervention Description
After GC5107A Intravenous injection, evaluate platelet increase
Primary Outcome Measure Information:
Title
% of patients who achieved the platelet count ≥ 50 x 10^9/L increase
Time Frame
within 7 days after intervention
Secondary Outcome Measure Information:
Title
Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss
Time Frame
4 weeks after intervention
Title
% patient with response
Description
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.
Time Frame
4 weeks after intervention
Title
% patient with complete response
Description
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.
Time Frame
4 weeks after intervention
Title
Duration of response
Description
measured from the achievement of R to loss of R
Time Frame
4 weeks after intervention
Title
Duration of complete response
Description
measured from the achievement of CR to loss of CR
Time Frame
4 weeks after intervention
Title
% patient with no response
Description
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.
Time Frame
4 weeks after intervention
Title
Descriptive statistics of platelet count at each visit
Time Frame
4 weeks after intervention
Title
Haemorrhage severity rate at each visit
Description
Haemorrhage severity score (HSS) system
Time Frame
4 weeks after intervention
Title
Quality of Life (EQ-5D)
Time Frame
4 weeks after intevention
Title
Patient reported bleeding events
Time Frame
12 weeks after intervention
Title
Usage of rescue mediations
Description
Rescue medications: Acetaminophen, antihistamines.
Time Frame
4 weeks after intervention
Title
Adverse events
Time Frame
12 weeks after intervention
Title
Drug compliance
Time Frame
2 days of intervention
Title
Viral safety
Time Frame
Base line, 4 weeks and 12 weeks after intervention
Title
Time to the achievement of platelet count ≥50x10^9/L increase
Time Frame
within 7 days after intervention
Other Pre-specified Outcome Measures:
Title
Pharmacokinetics of GC5107A
Description
Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85
Time Frame
12 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doyeun Oh, M.D., Ph.D.
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang-Hee Lee, M.D
Organizational Affiliation
Green Cross Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Deagu
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
CHA Budang Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chung Hyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
VHS Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29736158
Citation
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.
Results Reference
derived

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

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