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Immune ThrombocytopeniaPhase 3NCT05566990

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

A Phase 3 study testing LIV-GAMMA SN Inj.10% in people with Immune Thrombocytopenia, run by SK Plasma Co., Ltd. at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Immune Thrombocytopenia
What is being tested?
LIV-GAMMA SN Inj.10%
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
11 sitesSouth Korea
Study dates
19 Jul 2019to 26 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%
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  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Dong-A University Hospital

    Busan

  • Kosin University Gospel Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Kyungpook National University Hospital

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • Gachon University Gil Medical Center

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

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)

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%.

Being tested
LIV-GAMMA SN Inj.10%
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIV-GAMMA SN Inj.10%Biological

    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.

Study groups in NCT05566990
Study groupRoleWhat they receive
LIV-GAMMA SN Inj.10%ExperimentalNot described
Receives: Biological: LIV-GAMMA SN Inj.10%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder rate (CR or R)

    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

    Measured: 28 days

Secondary outcomes (6)

  1. The percentage of subjects with complete response (CR)

    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

    Measured: 28 days

  2. The percentage of subjects with response (R)

    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

    Measured: 28 days

  3. Time to response

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

    Measured: 28 days

  4. Duration of response

    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

    Measured: 28 days

  5. Bleeding

    Bleeding assessment with ITP-BAT bleeding grading system

    Measured: 28 days

  6. Adverse events

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start19 Jul 2019
  3. Primary completion3 Jun 2021
  4. Study completion26 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566990
Sponsor's protocol ID
IVIg10%_ITP_III_2019
Status last verified
Sep 2022
First submitted
30 Sep 2022
Last updated
5 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LIV-GAMMA SN Inj.10% in people with Immune Thrombocytopenia, run by SK Plasma Co., Ltd. at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate (CR or R) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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