A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Patients aged ≥18 years;
Newly diagnosed, treatment naïve ITP patients;
Patients with a platelet count <30 x10^9/L or a platelet count <50 x10^9/L with bleeding manifestations at the enrollment;
Willing and able to sign written informed consent.
Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);
Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);
Severe cardiac, renal, hepatic, or respiratory insufficiency;
Severe immunodeficiency;
Peking University People's Hospital
Lead sponsor
Peking University Health Science Center
Collaborator
Cisen Pharmaceutical CO., LTD.
Collaborator