The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
Peking University People's Hospital
132 participants
Aug 19, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Teriflunomide 14 mg orally once daily for 24 weeks.
Dexamethasone 40 mg orally once daily for four consecutive days.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07065968