Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP)
Phase of Trial: Phase III
Latest Information Update: 18 Sep 2019
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At a glance
- Drugs Immune globulin (Primary)
- Indications Thrombocytopenia
- Focus Registrational; Therapeutic Use
- Sponsors GC Pharma; Green Cross
- 07 May 2018 Primary endpoint (% of patients who achieved the platelet count 50 x 10^9/L increase-non-inferiority of efficacy) has been met, according to results published in the Journal of Korean Medical Science.
- 07 May 2018 According to results published in the Journal of Korean Medical Science, patients were enrolled from June 2014 to January 2016 and the follow-up of enrolled patients was completed on April 2016.The final analysis of this study was conducted in August 2016.
- 07 May 2018 Results published in the Journal of Korean Medical Science.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History