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;
Parallel
Dexamethasone
DrugDexamethasone, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)
Upadacitinib
DrugUpadacitinib 15mg qd for 12 weeks
Sustained response
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
complete response (CR)
complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Response (R)
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Number of patients with bleeding
Number of patients with bleeding complication ( WHO bleeding score).
Number of patients with adverse events
Number of patients with adverse events
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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
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