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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT02063789
First received: February 13, 2014
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Immune Thrombocytopenia
Drug: Human immunoglobulin intravenous
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • % of patients who achieved the platelet count ≥ 50 x 10^9/L increase [ Time Frame: within 7 days after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
  • % patient with response [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    measured from the achievement of R to loss of R

  • Duration of complete response [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    measured from the achievement of CR to loss of CR

  • % patient with no response [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
  • Haemorrhage severity rate at each visit [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    Haemorrhage severity score (HSS) system

  • Quality of Life (EQ-5D) [ Time Frame: 4 weeks after intevention ] [ Designated as safety issue: No ]
  • Patient reported bleeding events [ Time Frame: 12 weeks after intervention ] [ Designated as safety issue: No ]
  • Usage of rescue mediations [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]
    Rescue medications: Acetaminophen, antihistamines.

  • Adverse events [ Time Frame: 12 weeks after intervention ] [ Designated as safety issue: Yes ]
  • Drug compliance [ Time Frame: 2 days of intervention ] [ Designated as safety issue: No ]
  • Viral safety [ Time Frame: Base line, 4 weeks and 12 weeks after intervention ] [ Designated as safety issue: Yes ]
  • Time to the achievement of platelet count ≥50x10^9/L increase [ Time Frame: within 7 days after intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pharmacokinetics of GC5107A [ Time Frame: 12 weeks after intervention ] [ Designated as safety issue: No ]
    Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85


Enrollment: 81
Study Start Date: June 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063789

Locations
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
CHA Budang Medical Center
Seoul, Korea, Republic of
VHS 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
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
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
  More Information

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02063789     History of Changes
Other Study ID Numbers: GC5107A_P3 
Study First Received: February 13, 2014
Last Updated: May 23, 2016
Health Authority: Korea: Ministry of Food and Drug Safety

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

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

ClinicalTrials.gov processed this record on May 25, 2016