Actively Recruiting
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-11-18
10
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
CONDITIONS
Official Title
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form.
- Age at signing the informed consent form must be 18 years or older, regardless of gender.
- Confirmed diagnosis of primary Immune Thrombocytopenia for at least 3 months at screening.
- Previous treatment with corticosteroids.
- At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.
- Platelet count less than 30 x 10⁹/L at screening with clinical assessment indicating treatment necessity.
- Participants must have adequate organ function.
- Clinically stable condition with World Health Organization bleeding scale grade 0-1.
- Female participants of childbearing potential or male participants with fertile partners must agree to contraception from signing until 12 weeks after last dose.
You will not qualify if you...
- Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia.
- Received platelet transfusion, whole blood transfusion, plasma exchange, or emergency treatment drugs within 14 days prior to first SHR-2173 infusion.
- Received immunosuppressants (other than corticosteroids) such as JAK or BTK inhibitors within either 5 times the drug elimination half-life or 14 days prior to first infusion.
- Previous treatment with SHR-2173.
- Abnormal prothrombin time or activated partial thromboplastin time; concurrent coagulation disorders or use of antiplatelet or anticoagulant medications except low-dose aspirin.
- History of thrombotic or embolic events within 12 months prior to first administration or symptoms suggesting thrombophilia.
- Current life-threatening bleeding related to thrombocytopenia or expected emergency treatment within one week after randomization.
- Active infections requiring systemic treatment at screening, including tuberculosis or SARS-CoV-2 infection, or history of significant recurrent infections.
- Received live or attenuated vaccines within 8 weeks prior to first administration or planned during the trial.
- Diagnosis of myelodysplastic syndrome; history or current malignancy within 5 years prior to screening except certain cured cancers.
- Previous splenectomy.
- Previous allogeneic stem cell or organ transplantation except corneal transplantation at least 3 months prior; known or suspected immunosuppression.
- Planned surgery during dosing period.
- Severe or unstable pre-existing medical, psychiatric, or other conditions interfering with safety, consent, or compliance.
- Allergic constitution or known hypersensitivity to study drug or components.
- Concurrent participation in other investigational studies within 30 days prior or 5 half-lives of investigational drug.
- Females who are lactating or pregnant at screening or before administration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
J
Junye Xiong
CONTACT
Z
Zuxiang Jin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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