Clinical trial NCT02063789: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Keywords: Immune Thrombocytopenia
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Human Immunoglobulin
ITP
IVIg
IgIV
IV-Globulin SN Inj.
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 81
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % of patients who achieved the platelet count ≥ 50 x 10^9/L increase
timeFrame: within 7 days after intervention
Secondary outcomes:
measure: Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss
timeFrame: 4 weeks after intervention
measure: % patient with response
timeFrame: 4 weeks after intervention
measure: % patient with complete response
timeFrame: 4 weeks after intervention
measure: Duration of response
timeFrame: 4 weeks after intervention
measure: Duration of complete response
timeFrame: 4 weeks after intervention
measure: % patient with no response
timeFrame: 4 weeks after intervention
measure: Descriptive statistics of platelet count at each visit
timeFrame: 4 weeks after intervention
measure: Haemorrhage severity rate at each visit
timeFrame: 4 weeks after intervention
measure: Quality of Life (EQ-5D)
timeFrame: 4 weeks after intevention
measure: Patient reported bleeding events
timeFrame: 12 weeks after intervention
measure: Usage of rescue mediations
timeFrame: 4 weeks after intervention
measure: Adverse events
timeFrame: 12 weeks after intervention
measure: Drug compliance
timeFrame: 2 days of intervention
measure: Viral safety
timeFrame: Base line, 4 weeks and 12 weeks after intervention
measure: Time to the achievement of platelet count ≥50x10^9/L increase
timeFrame: within 7 days after intervention
Other outcomes:
measure: Pharmacokinetics of GC5107A
timeFrame: 12 weeks after intervention
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Deagu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: CHA Budang Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chung Hyang University Hospital
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
Study officials:
affiliation: CHA Bundang Medical Center
name: Doyeun Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Green Cross Corporation
name: Chang-Hee Lee, M.D
role: STUDY_DIRECTOR
References:
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.