A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

Sponsors

Lead Sponsor: SK Plasma Co., Ltd.

Source SK Plasma Co., Ltd.
Brief Summary

The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of LIV-GAMMA SN Inj.

Overall Status Unknown status
Start Date September 27, 2016
Completion Date August 30, 2018
Primary Completion Date April 3, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Responder rate (CR or R) 28 days
Secondary Outcome
Measure Time Frame
The percentage of subjects with complete response (CR) 28 days
The percentage of subjects with response (R) 28 days
Time to Response 28 days
Duration of response 28 days
Bleeding 28 days
Enrollment 37
Condition
Intervention

Intervention Type: Biological

Intervention Name: LIV-GAMMA SN Inj.

Arm Group Label: LIV-GAMMA SN Inj.

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of ITP

- Mean screening platelet count of <30×10^9/L from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10^9/L.

- No other factors inducing ITP

- Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study.

Exclusion Criteria:

- Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G

- Immunoglobulin A (IgA) deficiency

- Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj.

- Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj.

- Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj.

- Treatment with anti-coagulants, which may affect the function of platelet

- Positive HIV, HBV, HCV

- 3-fold increase of ALT or AST compared to normal upper limit

- eCFR < 30mL/min/1.73m^2

- History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances

- Hemoglobin > 10g/dL

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jong Wook Lee, MD Study Chair The Catholic University of Korea
Location
Facility:
Busan National University Hospital | Busan, Korea, Republic of
Bundang Seoul National University Hospital | Seongnam, Korea, Republic of
Samsung Medical Center | Seoul, Korea, Republic of
Severance Hospital | Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul, Korea, Republic of
Yangsan Busan National University Hospital | Yangsan, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

April 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: LIV-GAMMA SN Inj.

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov