A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

• Sponsor: SK Plasma Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05566990
• Collaborator: (none)
• Enrollment: 34
• Locations: 11
• Arm: 1
• Actual Duration (Months): 28.3
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (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 time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Biological: LIV-GAMMA SN Inj.10%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)
• Actual Study Start Date: Jul 19, 2019
• Actual Primary Completion Date: Jun 3, 2021
• Actual Study Completion Date: Nov 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LIV-GAMMA SN Inj.10%	Biological: LIV-GAMMA SN Inj.10%; LIV-GAMMA SN Inj. 10% is administered intravenously at a dose of 1 g/kg daily for 2 consecutive days to patients with primary immune thrombocytopenia.

Outcome Measures

Primary Outcome Measures

1. Responder rate (CR or R) [28 days]

   The rate of subjects with complete response (CR) defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding or response (R) defined as cases with a platelet count ≥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 with an absence of bleeding

Secondary Outcome Measures

1. The percentage of subjects with complete response (CR) [28 days]

   The percentage of subjects with complete response (CR) defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding

2. The percentage of subjects with response (R) [28 days]

   The percentage of subjects with response (R) defined as cases with a platelet count ≥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 with an absence of bleeding

3. Time to response [28 days]

   The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved

4. Duration of response [28 days]

   The time from the achievement of complete response (CR) or response (R) to the day when loss of complete response (CR) or response (R) is achieved

5. Bleeding [28 days]

   Bleeding assessment with ITP-BAT bleeding grading system

6. Adverse events [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed informed consent process

• Male or female aged ≥19 years

• Diagnosis of chronic ITP (≥12 months since diagnosis)

• 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

• If the patient is taking corticosteroid, attenuated androgen, cyclophosphamide, azathioprine or other drugs for ITP, the treatment regimen and dose should be stable at least 1 month prior to screening and should be lasted during this study

• Females of child-bearing potential with a negative urine pregnancy test and who agree with contraception during this study

Exclusion Criteria:

• Patients who have allergy or hypersensitivity to blood products, blood-derived products, intravenous immunoglobulin (IVIg) or immunoglobulin G (IgG)

• Patients who have immunoglobulin A (IgA) deficiency

• Patients who were immunized with live attenuated vaccines within 12 months from the first administration of LIV-GAMMA SN Inj.10%

• Patients who had received IVIg or blood/blood-derived products within 1 month from the first administration of LIV-GAMMA SN Inj.10%

• Patients who had received other investigational products within 1 month from the first administration of LIV-GAMMA SN Inj.10%

• Patients who had received Rituximab within 3 months from the first administration of LIV-GAMMA SN Inj.10%

• Patients who were taking anticoagulants or other agents related to platelet function (e.g., Aspirin, other NSAID) at the time of screening

• Patients who are pregnant and nursing

• Patients who are positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at the time of screening

• Patients who have 3-fold higher levels of alanine transaminase (ALT), aspartate transaminase (AST) than the upper limit of normal at the time of screening

• Patients who suffered from severe renal impairment (eGFR<30 mL/min/1.73 m^2 at the time of screening)

• Patients who had history of deep vein thrombosis (DVT) or thrombotic complications against IVIg therapy

• Patients who had history of neurovascular or cardiovascular disorders (e.g., Blood hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolism, unstable angina)

• Patients who have an ongoing history of acute or chronic condition that affect to the participation of this study

• Patients who have an ongoing history of medical condition inducing secondary immune deficiency (e.g., Leukemia, lymphoma, multiple myeloma, HIV infection, chronic or cyclic neutropenia (absolute neutrophil count<500/mm^3)

• Patients who are suffering from hypertension (systolic blood pressure>160 mmHg or diastolic blood pressure>100 mmHg)

• Patients who have hemoglobin level≤10 g/dL at the time of screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dong-A University Hospital	Busan		Korea, Republic of
2	Kosin University Gospel Hospital	Busan		Korea, Republic of
3	Pusan National University Hospital	Busan		Korea, Republic of
4	Kyungpook National University Hospital	Daegu		Korea, Republic of
5	Chungnam National University Hospital	Daejeon		Korea, Republic of
6	Gachon University Gil Medical Center	Incheon		Korea, Republic of
7	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
8	Samsung Medical Center	Seoul		Korea, Republic of
9	Seoul National University Hospital	Seoul		Korea, Republic of
10	Severance Hospital	Seoul		Korea, Republic of
11	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• SK Plasma Co., Ltd.

Investigators

• Study Chair: Jong Wook Lee, MD, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Plasma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05566990
• Other Study ID Numbers: IVIg10%_ITP_III_2019
• First Posted: Oct 5, 2022
• Last Update Posted: Oct 5, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Oct 5, 2022