Immune ThrombocytopeniaPhase 3NCT03164915
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
A Phase 3 study testing LIV-GAMMA SN Inj. in people with Immune Thrombocytopenia, run by SK Plasma Co., Ltd. at 6 sites in South Korea.
Trial summary
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 24 Oct 2016to 28 Sep 2018
- 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
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Busan National University Hospital
Busan
Bundang Seoul National University Hospital
Seongnam
Samsung Medical Center
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Yangsan Busan National University Hospital
Yangsan
About this study
Official title: A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with 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 duration of response, and the safety of LIV-GAMMA SN Inj.
- Conditions
- Immune Thrombocytopenia
- Being tested
- LIV-GAMMA SN Inj.
- 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.Biological
| Study group | Role | What they receive |
|---|---|---|
| LIV-GAMMA SN Inj. | Experimental | Not described Receives: Biological: LIV-GAMMA SN Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate (CR or R)
The rate of subjects with complete response defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥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 without bleeding
Measured: 28 days
Secondary outcomes (5)
The percentage of subjects with complete response (CR)
The percentage of subjects with CR defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
Measured: 28 days
The percentage of subjects with response (R)
The percentage of subjects with R defined as cases with a platelet count of ≥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 without bleeding
Measured: 28 days
Time to Response
The time from the start of treatment to the time of achievement of CR or R
Measured: 28 days
Duration of response
the time from the achievement of CR or R to loss of CR or R
Measured: 28 days
Bleeding
Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start24 Oct 2016
- Primary completion3 Apr 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Plasma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong Wook Lee, MD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164915
- Sponsor's protocol ID
- IVIg_ITP_III_2016
- Status last verified
- Mar 2021
- First submitted
- 22 May 2017
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT03164915
- Acronym / sponsor ID
- IVIg_ITP_III_2016
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SK Plasma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with 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 duration of response, and the safety of LIV-GAMMA SN Inj.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIV-GAMMA SN Inj. | Experimental | Biological: LIV-GAMMA SN Inj. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIV-GAMMA SN Inj. | Biological | LIV-GAMMA SN Inj. |
Primary outcome
Responder rate (CR or R)
Time frame: 28 days
The rate of subjects with complete response defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥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 without bleeding
5 secondary outcomes
The percentage of subjects with complete response (CR)
Time frame: 28 days
The percentage of subjects with response (R)
Time frame: 28 days
Time to Response
Time frame: 28 days
Duration of response
Time frame: 28 days
Bleeding
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Wook Lee, MD study chair
The Catholic University of Korea
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LIV-GAMMA SN Inj. in people with Immune Thrombocytopenia, run by SK Plasma Co., Ltd. at 6 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 4 inclusion and 11 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 30 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.