Immune Thrombocytopenia Clinical Trial
Official title:
The Combination of Iguratimod and Danazol Versus Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial
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 thrombocytopenia (ITP).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | |
China | Zhuo-Yu An | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | Beijing Friendship Hospital, Beijing Hospital, China-Japan Friendship Hospital, First Affiliated Hospital of Chongqing Medical University, Shanxi Bethune hospital, Shanxi, China, The First Affiliated Hospital of Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sustained response | The maintenance of platelet count = 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up. Interim analysis was scheduled at 50% through recruitment. | 6 months | |
Secondary | Complete remission | The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding. | 6 months | |
Secondary | Partial remission | The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) without the administration of any other platelet increasing therapy. | 6 months | |
Secondary | Time to response | Time to response was defined as the time from starting treatment to the time to achieve the response. | 6 months | |
Secondary | Duration of response | Duration of response was measured from the achievement of response to the loss of response. | 6 months | |
Secondary | Incidence of treatment-emergent adverse events | Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 6 months |
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