Status and phase
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About
To select a dose and to make a decision for Phase 3 study
Full description
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 3 patient groups, including a placebo group
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Central trial contact
Shuai Zhao
Data sourced from clinicaltrials.gov
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