CompletedNCT03164915Updated Mar 30, 2021

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

A Phase 3 interventional study of LIV-GAMMA SN Inj. in Immune Thrombocytopenia, sponsored by SK Plasma Co., Ltd.. Completed at 6 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by SK Plasma Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Oct 2016, registered May 2017).

Phase: Phase 3
Study type: Interventional
Enrollment: 37
Allocation: Not applicable
Ages: 19 Years and older
Sex: All

Study 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.

Conditions studied

Immune Thrombocytopenia

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In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's enrollment of 37 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

SK Plasma Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
LIV-GAMMA SN Inj.
Biological: LIV-GAMMA SN Inj.

Interventions

BiologicalLIV-GAMMA SN Inj.

What researchers measure

Primary outcomes

Responder rate (CR or R)
The rate of subjects with complete response defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
Time frame: 28 days

Secondary outcomes

The percentage of subjects with complete response (CR)
The percentage of subjects with CR defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
Time frame: 28 days
The percentage of subjects with response (R)
The percentage of subjects with R defined as cases with a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
Time frame: 28 days
Time to Response
The time from the start of treatment to the time of achievement of CR or R
Time frame: 28 days
Duration of response
the time from the achievement of CR or R to loss of CR or R
Time frame: 28 days
Bleeding
Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Time frame: 28 days

Study locations

6 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03164915
Lead sponsor: SK Plasma Co., Ltd.
Responsible party: Sponsor
First posted: May 24, 2017
Start date: Oct 24, 2016
Primary completion: Apr 3, 2018
Completion: Sep 28, 2018
Last update: Mar 30, 2021

Study contacts

Jong Wook Lee, MD

study chair · The Catholic University of Korea

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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