Trials / Completed
CompletedNCT03164915
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- SK Plasma Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LIV-GAMMA SN Inj. |
Timeline
- Start date
- 2016-10-24
- Primary completion
- 2018-04-03
- Completion
- 2018-09-28
- First posted
- 2017-05-24
- Last updated
- 2021-03-30
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03164915. Inclusion in this directory is not an endorsement.