drugset / Trial / NCT06176235
Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia
Phase 2
Withdrawn
Peking University People's Hospital
Beijing Friendship Hospital · collabBeijing Hospital · collabBeijing Luhe Hospital · collabBeijing Tsinghua Changgeng Hospital · collabChina-Japan Friendship Hospital · collabChinese PLA General Hospital · collabNavy General Hospital, Beijing · collabPeking University First Hospital · collabPeking University Third Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized, open-label, multicenter study to compare 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).
Timeline
- Start
- 2023-12-19
- Primary completion
- 2024-12-12
- Completion
- 2025-05-12
Outcome
Outcome not reported
Stopped (Enrollment): “Trial withdrawn due to substantial protocol amendments invalidating the original design. With no participants enrolled, this aligns with WHO-ICTRP guidelines. Recruitment has ceased, and the revised protocol has been re-registered as NCT07065968.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Teriflunomide | Small molecule | 7 mg | Oral |