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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT03164915
• Date of registration: 22/05/2017
• Prospective Registration: No
• Primary sponsor: SK Plasma Co., Ltd.
• Public title: A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
• Scientific title: A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
• Date of first enrolment: October 24, 2016
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03164915
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jong Wook Lee, MD
• Affiliation: The Catholic University of Korea

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenia

Intervention(s)

Biological: LIV-GAMMA SN Inj.

Primary Outcome(s)

Responder rate (CR or R) [Time Frame: 28 days]

Secondary Outcome(s)

Time to Response [Time Frame: 28 days]

Duration of response [Time Frame: 28 days]

Bleeding [Time Frame: 28 days]

The percentage of subjects with complete response (CR) [Time Frame: 28 days]

The percentage of subjects with response (R) [Time Frame: 28 days]

Secondary ID(s)

IVIg_ITP_III_2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors