NCT07065968 The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
| NCT ID | NCT07065968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Immune Thrombocytopenia (ITP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2027-09-10 |
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥18 years; 2. Newly diagnosed, treatment naïve ITP patients; 3. Patients with a platelet count \<30 x10\^9/L or a platelet count \<50 x10\^9/L with bleeding manifestations at the enrollment; 4. Willing and able to sign written informed consent. Exclusion Criteria: 1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus); 2. Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN); 3. Severe cardiac, renal, hepatic, or respiratory insufficiency; 4. Severe immunodeficiency; 5. Pregnancy or lactation; 6. Active or a history of malignancy; 7. Active infection requiring systemic therapy; 8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis; 9. A known diagnosis of other autoimmune diseases; 10. Patients who are deemed unsuitable for the study by the investigator.