The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Recruiting now · Phase 2
Conditions studied: Immune Thrombocytopenia (ITP)
In brief
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).
Key facts
- Study ID
- NCT07065968
- Run by
- Peking University People's Hospital
- People needed
- 132
- Starts
- 2025-08-19
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2025-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
- Peking University Insititute of Hematology, Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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