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

StatusRecruiting
PhasePhase 2
Started2025-08-19
View on ClinicalTrials.gov ↗

Amendment history

2025-08-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-15→confirmed 2025-08-19
Study sitesdetails revised at 3 of 3 sites
2025-07-04
minor
Original filing
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 Details
NCT Number NCT07065968
Lead Sponsor Peking University People's Hospital
Collaborators: Peking University Health Science Center, Cisen Pharmaceutical CO., LTD.
Conditions Immune Thrombocytopenia (ITP)
Enrollment 132 participants
Start Date 2025-08-19
Primary Completion 2027-09-10 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-08