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โ† Trials
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The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

RecruitingPhase 2Ages 18 Years - anyAllPeking University People's Hospital
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged โ‰ฅ18 years; 2. Newly diagnosed, treatment naรฏve 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.
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What it tests

  • Teriflunomide
  • Dexamethasone
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Where

3 sites
Peking University First Hospital
Beijing, China
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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