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).
1 other identifier
interventional
81
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2014
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 25, 2016
May 1, 2016
1.8 years
February 13, 2014
May 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% of patients who achieved the platelet count ≥ 50 x 10^9/L increase
within 7 days after intervention
Secondary Outcomes (15)
Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss
4 weeks after intervention
% patient with response
4 weeks after intervention
% patient with complete response
4 weeks after intervention
Duration of response
4 weeks after intervention
Duration of complete response
4 weeks after intervention
- +10 more secondary outcomes
Other Outcomes (1)
Pharmacokinetics of GC5107A
12 weeks after intervention
Study Arms (1)
Human immunoglobulin intravenous
EXPERIMENTALHuman 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.
Interventions
After GC5107A Intravenous injection, evaluate platelet increase
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Related Publications (1)
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.
PMID: 29736158DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doyeun Oh, M.D., Ph.D.
CHA Bundang Medical Center
- STUDY DIRECTOR
Chang-Hee Lee, M.D
Green Cross Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2014
First Posted
February 14, 2014
Study Start
June 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 25, 2016
Record last verified: 2016-05