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

September 30, 2022 updated by: SK Plasma Co., Ltd.

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Dong-A University Hospital
      • Busan, Korea, Republic of
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder rate (CR or R)
Time Frame: 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
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 28 days
28 days
The percentage of subjects with complete response (CR)
Time Frame: 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
28 days
The percentage of subjects with response (R)
Time Frame: 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
28 days
Time to response
Time Frame: 28 days
The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved
28 days
Duration of response
Time Frame: 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
28 days
Bleeding
Time Frame: 28 days
Bleeding assessment with ITP-BAT bleeding grading system
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SK Plasma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jong Wook Lee, MD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IVIg10%_ITP_III_2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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