Clinical trial NCT03164915: A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
Official title: A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Lead sponsor: SK Plasma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 37
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: 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.


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

Primary outcomes:
measure: Responder rate (CR or R)
timeFrame: 28 days
Secondary outcomes:
measure: The percentage of subjects with complete response (CR)
timeFrame: 28 days
measure: The percentage of subjects with response (R)
timeFrame: 28 days
measure: Time to Response
timeFrame: 28 days
measure: Duration of response
timeFrame: 28 days
measure: Bleeding
timeFrame: 28 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
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: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Yangsan
country: Korea, Republic of
facility: Yangsan Busan National University Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jong Wook Lee, MD
role: STUDY_CHAIR
References: