Immune Thrombocytopenia Clinical Trial
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)
Verified date | March 2021 |
Source | SK Plasma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | September 28, 2018 |
Est. primary completion date | April 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Busan National University Hospital | Busan | |
Korea, Republic of | Bundang Seoul National University Hospital | Seongnam | |
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 | Seoul | |
Korea, Republic of | Yangsan Busan National University Hospital | Yangsan |
Lead Sponsor | Collaborator |
---|---|
SK Plasma Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28 days | |
Secondary | 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 | 28 days | |
Secondary | 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 | 28 days | |
Secondary | Time to Response | The time from the start of treatment to the time of achievement of CR or R | 28 days | |
Secondary | Duration of response | the time from the achievement of CR or R to loss of CR or R | 28 days | |
Secondary | Bleeding | Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP) | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
Completed |
NCT02556814 -
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
|
Phase 4 | |
Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
Terminated |
NCT02401061 -
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
|
Phase 1/Phase 2 | |
Completed |
NCT02351622 -
Caffeic Acid Tablets as a Second-line Therapy for ITP
|
Phase 3 | |
Active, not recruiting |
NCT04741139 -
Post IVIG Medication in Children With Immune Thrombocytopenia
|
Phase 1 | |
Not yet recruiting |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
Not yet recruiting |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Recruiting |
NCT04993885 -
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
|
Phase 2 | |
Recruiting |
NCT05281068 -
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Not yet recruiting |
NCT05020288 -
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
|
Phase 2 | |
Withdrawn |
NCT03965624 -
Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia
|
Phase 2 | |
Not yet recruiting |
NCT03252457 -
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
|
Phase 3 | |
Recruiting |
NCT05937828 -
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
|
||
Completed |
NCT03156452 -
Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate
|
Phase 3 | |
Recruiting |
NCT02270801 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
|
Phase 3 | |
Withdrawn |
NCT01976195 -
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
|
Phase 2 | |
Completed |
NCT01933035 -
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
|
N/A | |
Recruiting |
NCT02821572 -
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
|
||
Not yet recruiting |
NCT05562882 -
A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
|
Early Phase 1 |