A Single-arm, Open-label Phase II Study to Determine the Safety and Efficacy of Teriflunomide in Patients With Steroid-resistant/Relapse Thrombocytopenia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosis of primary immune thrombocytopenia (ITP) by excluding other supervened causes of thrombocytopenia
• Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
• Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;
• Willing and able to sign written informed consent.
Locations
Other Locations
China
Peking University Insititute of Hematology, Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiao-Hui Zhang, MD
zhangxh100@sina.com
+8613522338836
Backup
Li-Ping Yang, MD
lpyangvip@163.com
+8618519172033
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2025-06-15
Participants
Target number of participants: 40
Treatments
Experimental: Teriflunomide
Oral Teriflunomide is given at a dose of 7 mg once daily with dose adjustments for 24 weeks. Treatment was discontinued if a dose-limiting toxic effect occurred, rescue medication was used, or concomitant medication for immune thrombocytopenia was changed beyond the 10% level as defined above.
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital