Actively Recruiting
A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
Led by Dizal Pharmaceuticals · Updated on 2026-01-22
60
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP). The target population of this study is patients with primary ITP who had failed to respond or relapsed after receiving at least one standard therapy. Participants who meet the inclusion criteria and do not meet the exclusion criteria will be randomized to different dose groups.
CONDITIONS
Official Title
A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 years of age or older
- Diagnosed with persistent or chronic primary ITP with average platelet counts less than 30 × 10⁹/L
- Have failed at least one standard ITP treatment such as glucocorticoids or IVIG
- Have adequate bone marrow reserve and organ function
- Willing to follow contraceptive restrictions
You will not qualify if you...
- Evidence of secondary causes of immune thrombocytopenia
- History of coagulation disorders other than ITP, including disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
- Previous or current treatments prohibited by the study protocol
- Severe heart abnormalities
- Active infections
- Poorly controlled gastrointestinal disorders or inadequate medication absorption
- Known allergy to DZD8586 or related chemical compounds
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
C
Cong Wei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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