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

NCT ID: NCT02063789

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human immunoglobulin intravenous

Intervention Type: DRUG

After GC5107A Intravenous injection, evaluate platelet increase

Interventions

Human immunoglobulin intravenous

After GC5107A Intravenous injection, evaluate platelet increase

Intervention Type: DRUG

Other Intervention Names

GC5107A (IV-Globulin SN Inj. 10%)

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doyeun Oh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Chang-Hee Lee, M.D

Role: STUDY_DIRECTOR

Green Cross Corporation

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Daegu Catholic University Medical Center

Deagu, , South Korea

Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Asan Medical Center

Seoul, , South Korea

CHA Budang Medical Center

Seoul, , South Korea

Ewha Womans University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Soon Chung Hyang University Hospital

Seoul, , South Korea

VHS Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29736158 (View on PubMed)

Other Identifiers

GC5107A_P3

Identifier Type: -

Identifier Source: org_study_id