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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Peking University Insititute of Hematology, Peking University People's Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiao-Hui Zhang, MD
zhangxh@bjmu.edu.cn
+8613522338836
Backup
Li-Ping Yang, MD
lpyang@bjmu.edu.cn
+8618519172033
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 132
Treatments
Experimental: Teriflunomide plus Dexamethasone
Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.
Active_comparator: Dexamethasone
Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital
Collaborators: Peking University Health Science Center, Cisen Pharmaceutical CO., LTD.