A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DZD8586 dose level 1, DZD8586 dose level 2, DZD8586 dose level 3.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
Overview
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.
Interventions
- Drug DZD8586 dose level 1
DZD8586 will be administered orally in a 28-day cycle. - Drug DZD8586 dose level 2
DZD8586 will be administered orally in a 28-day cycle. - Drug DZD8586 dose level 3
DZD8586 will be administered orally in a 28-day cycle.
Primary outcome measures
- Overall response rate (4 weeks) [Time frame: within 4 weeks]
Secondary outcome measures (4)
- Incidence and severity of Adverse Events (AEs) [Time frame: 30 days after the last dose]
- Overall response rate (12 weeks) [Time frame: within 12 weeks]
- Durable response rate [Time frame: within 24 weeks]
- Time to response [Time frame: within 24 weeks]
Eligibility criteria
Inclusion criteria
- Male and female participants ≥ 18 years of age.
- Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts < 30 × 10⁹/L.
- Have failed at least one standard treatment for ITP (glucocorticoids and/or IVIG).
- Adequate bone marrow reserve and organ functions.
- Willing to comply with contraceptive restrictions.
Exclusion criteria
- Have evidence of secondary causes of immune thrombocytopenia.
- Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- Any of previous or current treatment prohibited by protocol.
- Any of severe cardiac abnormalities.
- Active infection.
- Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- Known allergy to DZD8586 drug excipients or other chemical analogues.
- Pregnant or breastfeeding female participants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT07294365 · DZ2025B0002