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CompletedNCT05566990Updated Oct 5, 2022

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

A Phase 3 interventional study of LIV-GAMMA SN Inj.10% in Immune Thrombocytopenia, sponsored by SK Plasma Co., Ltd.. Completed at 11 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by SK Plasma Co., Ltd. (formerly part of SK Chemicals Co., Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Jul 2019, registered Sep 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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%.

02

Conditions studied

  • Immune Thrombocytopenia
03

In context

Purpura, Thrombocytopenic, Idiopathic

521 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.

This study's enrollment of 34 is below the median of 58 across 383 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.

Browse Purpura, Thrombocytopenic, Idiopathic studies →

Lead sponsor

SK Plasma Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

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

Study arms

  • Experimental
    LIV-GAMMA SN Inj.10%

    Biological: LIV-GAMMA SN Inj.10%

Interventions

  • BiologicalLIV-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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 28 days

Secondary outcomes

  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

    Time frame: 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

    Time frame: 28 days

  3. Time to response

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

    Time frame: 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

    Time frame: 28 days

  5. Bleeding

    Bleeding assessment with ITP-BAT bleeding grading system

    Time frame: 28 days

  6. Adverse events

    Time frame: 28 days

07

Study locations

11 sites
  • Dong-A University Hospital
    Busan, South Korea
  • Kosin University Gospel Hospital
    Busan, South Korea
  • Pusan National University Hospital
    Busan, South Korea
  • Kyungpook National University Hospital
    Daegu, South Korea
  • Chungnam National University Hospital
    Daejeon, South Korea
  • Gachon University Gil Medical Center
    Incheon, South Korea
  • Seoul National University Bundang Hospital
    Seongnam, South Korea
  • Samsung Medical Center
    Seoul, South Korea
  • Seoul National University Hospital
    Seoul, South Korea
  • Severance Hospital
    Seoul, South Korea
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Jun 2021, 22 months.

Of 43 industry-sponsored phase 3 interventional studies under Purpura, Thrombocytopenic, Idiopathic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 44. This study's 22 months is below that.

Counting every sponsor, half of 59 studies reached it within 28 months; a quarter within 21 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2022
First posted
Oct 5, 2022
StartActual
Jul 19, 2019
Primary completionActual
Jun 3, 2021
CompletionActual
Nov 26, 2021
Last update
Oct 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05566990
Responsible party
Sponsor
First posted
Oct 5, 2022
Start date
Jul 19, 2019
Primary completion
Jun 3, 2021
Completion
Nov 26, 2021
Last update
Oct 5, 2022

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 ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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