Randomized, open-label, multicenter study to compare the efficacy and safety of Upadacitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).
Confirmed newly-diagnosed, treatment-naive ITP;
Platelet counts <30×109/L ;
Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
Willing and able to sign written informed consent.
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
Current HIV infection or hepatitis B virus or hepatitis C virus infections;
Active infection;
Peking University People's Hospital
Lead sponsor
Beijing Hospital
Collaborator
Navy General Hospital, Beijing
Collaborator
Beijing Aerospace General Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Tongren Hospital
Collaborator