Status:
UNKNOWN
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Hospital
China-Japan Friendship Hospital
Conditions:
ITP
Immune Thrombocytopenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune ...
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to Iguratimod plus dan...
Eligibility Criteria
Inclusion
- Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×109/L at 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;
- 18 years older;
Exclusion
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- Congestive heart failure
- Severe arrhythmia
- Nursing or pregnant women
- Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
- Active or previous malignancy
- Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05281068
Start Date
September 1 2021
End Date
December 30 2023
Last Update
May 2 2022
Active Locations (2)
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1
Zhuo-Yu An
Beijing, China, 100044
2
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China