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
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%.
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 →SK Plasma Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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
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
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
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
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
Bleeding
Bleeding assessment with ITP-BAT bleeding grading system
Time frame: 28 days
Adverse events
Time frame: 28 days
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.
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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Purpura, Thrombocytopenic, Idiopathic →