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Phase 2
Age: 18Years +
All Genders
ID07294365

Phase 2 Study of Oral DZD8586 for Adults with Primary Immune Thrombocytopenia ITP Who Did Not Respond to Standard Treatment

Led by Dizal Pharmaceuticals · Updated on 2026-01-22

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a drug called DZD8586 in adults diagnosed with primary immune thrombocytopenia ITP who have not responded to or relapsed after standard treatments. This Phase 2, open-label, randomized study focuses on patients with persistent or chronic primary ITP, aiming to find out how well different doses of DZD8586 work in this population. Participants will be randomly assigned to receive one of three different dose levels of DZD8586, taken orally once a day in 28-day cycles. The study involves multiple centers and assesses the drugs impact over several weeks, monitoring participants through these defined dosing groups. During the study, participants will undergo regular evaluations to measure their platelet counts and response rates at 4, 12, and 24 weeks. Safety will be monitored by tracking adverse events for 30 days after the last dose. Researchers will also observe the time it takes for participants to respond to treatment and the durability of that response. The total duration and detailed follow-up are planned to ensure comprehensive assessment of the treatments effects.

CONDITIONS

Brief Title

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

Research Team

C

Cong Wei

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