Overview
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).
Description
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Pregnancy or lactation;
- Active or a history of malignancy;
- Active infection requiring systemic therapy;
- Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;
- A known diagnosis of other autoimmune diseases;
- Patients who are deemed unsuitable for the study by the investigator.