A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Comparing the Efficacy and Safety of Teriflunomide Plus Danazol in Patients With Steroid-resistant/Relapse ITP
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
• 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;
• Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
• 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: 2025-07-15
Participants
Target number of participants: 124
Treatments
Experimental: Teriflunomide plus danazol
Oral teriflunomide was given at a starting dose of 7 mg once daily and danazol was given at a dose of 200mg twice daily for 24 weeks. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.
Active_comparator: Danazol
Danazol was given at a dose of 200 mg twice a day for 24 weeks. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.
Related Therapeutic Areas
Sponsors
Collaborators: China-Japan Friendship Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Luhe Hospital, Beijing Friendship Hospital, Peking University First Hospital, Peking University Third Hospital, Beijing Hospital, Navy General Hospital, Beijing, Chinese PLA General Hospital
Leads: Peking University People's Hospital