Phase 3 Study of Intravenous Human Immunoglobulin 5% to Treat Adults with Primary Immune Thrombocytopenia Aged 18 to 65

What this Trial Is About

This trial investigates the use of a medicinal product called Human Immunoglobulin for Intravenous Injection 5% to evaluate its safety and effectiveness in treating patients with primary Immune Thrombocytopenia ITP. This is a Phase III open-label study conducted at multiple centers, involving patients aged 18 to 65 years with confirmed chronic ITP and low platelet counts. The study is sponsored by Grand Shuyang Life Sciences Chengdu Co., Ltd. Participants will receive the investigational product, 5% IVIG, administered as a direct intravenous drip at a dose of 0.4 gkg daily for 5 consecutive days. The infusion rate starts at 1.0 mlmin and may increase if well tolerated, not exceeding 3.0 mlmin. The study consists of four periods including screening, baseline, treatment in a hospital setting, and follow-up visits on days 6, 7, 14, 21, 28, and 90 after the first dose. During approximately 104 days of participation, patients will attend nine scheduled visits for assessments including blood tests to monitor platelet counts and ITP bleeding scores. Researchers will measure treatment response within 7 days of infusion and track platelet counts and bleeding outcomes for up to 28 days. Safety and efficacy will be closely monitored throughout the trial, but the investigational product will only be provided during the study period and not after its completion.

An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia