Phase III Study of TQB3473 Tablets Versus Placebo for Treating Adults with Primary Immune Thrombocytopenia Who Have Tried Standard Treatments

What this Trial Is About

Researchers are evaluating the effectiveness and safety of TQB3473 tablets compared to a placebo in adults with primary immune thrombocytopenia ITP who have not responded well to standard corticosteroid and other ITP treatments. This randomized, double-blind, placebo-controlled Phase III clinical trial aims to show that TQB3473 can improve the sustained platelet response rate in these patients. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will be randomly assigned to receive either TQB3473 tablets at a dose of 600 mg once daily or a placebo once daily, both for 24 consecutive weeks. The study includes a treatment period followed by a safety follow-up period. The trial carefully monitors platelet counts and bleeding events throughout the treatment duration. During the study, participants will have regular assessments including platelet count measurements, evaluations of bleeding events, and monitoring for any adverse effects. Researchers will track the durable response rate between weeks 14 and 24, as well as response rates and effectiveness within the first 12 weeks. Safety is closely monitored from consent signing until 28 days after the last dose or the start of new ITP treatment. The total participation covers the treatment and safety follow-up periods.

A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia