The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07065968
- Record updated
- 8 September 2025
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus); Severe cardiac, renal, hepatic, or respiratory insufficiency; Active or a history of malignancy; Active infection requiring systemic therapy; Myelodysplastic syndrome, aplastic anemia, or myelofibrosis; A known diagnosis of other autoimmune diseases; Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN); Severe immunodeficiency; Pregnancy or lactation; Patients who are deemed unsuitable for the study by the investigator.