Primary Immune Thrombocytopenic Purpura Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia
To select a dose and to make a decision for Phase 3 study
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04890041 -
TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
|
N/A |