The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Recruiting
Phase 2
Interventional Study
Immune Thrombocytopenia (ITP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 132 (estimated)
- Sponsor
- Peking University People's Hospital · Other
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About This 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).
Trial Locations
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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 Criter…
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