A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
NCT07083739 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2025-07-24
Summary
This study is an extension of the TQB3473-III-01 study, aimed at evaluating the safety and efficacy of TQB3473 tablets in adult patients with persistent or chronic ITP who have received at least one ITP standard treatment that is ineffective or has recurred after treatment. This is a single arm, open label, multi cohort, multi center Phase II clinical study.
Conditions
- Primary Immune Thrombocytopenia
Interventions
- DRUG
-
TQB3473 Tablets
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-31
- Primary Completion
- 2027-09-30
- Completion
- 2028-03-31
Countries
- China
Study Locations
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