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

Immune Thrombocytopenia Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063789
• Other study ID #: GC5107A_P3
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2014
• Last updated: May 23, 2016
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Human immunoglobulin intravenous
After GC5107A Intravenous injection, evaluate platelet increase

Locations

Country	Name	City	State
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	Asan Medical Center	Seoul
Korea, Republic of	CHA Budang 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	VHS Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics of GC5107A	Day 1(pre-dosing, post dosing), 2 (pre-dosing, post dosing), 4, 8, 15, 29, and 85	12 weeks after intervention	No
Primary	% of patients who achieved the platelet count = 50 x 10^9/L increase		within 7 days after intervention	No
Secondary	Duration from the achievement of platelet count = 50 x 10^9/L increase to the loss		4 weeks after intervention	No
Secondary	% 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.	4 weeks after intervention	No
Secondary	% 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.	4 weeks after intervention	No
Secondary	Duration of response	measured from the achievement of R to loss of R	4 weeks after intervention	No
Secondary	Duration of complete response	measured from the achievement of CR to loss of CR	4 weeks after intervention	No
Secondary	% 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.	4 weeks after intervention	No
Secondary	Descriptive statistics of platelet count at each visit		4 weeks after intervention	No
Secondary	Haemorrhage severity rate at each visit	Haemorrhage severity score (HSS) system	4 weeks after intervention	No
Secondary	Quality of Life (EQ-5D)		4 weeks after intevention	No
Secondary	Patient reported bleeding events		12 weeks after intervention	No
Secondary	Usage of rescue mediations	Rescue medications: Acetaminophen, antihistamines.	4 weeks after intervention	No
Secondary	Adverse events		12 weeks after intervention	Yes
Secondary	Drug compliance		2 days of intervention	No
Secondary	Viral safety		Base line, 4 weeks and 12 weeks after intervention	Yes
Secondary	Time to the achievement of platelet count =50x10^9/L increase		within 7 days after intervention	No