The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
- Registration Number
- NCT05281068
- Lead Sponsor
- Peking University People's Hospital
- 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 thrombocytopenia (ITP).
- 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 danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iguratimod and Danazol Iguratimod Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks. Iguratimod and Danazol Danazol Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks. Danazol Danazol Danazol is given at 200mg bid for 12 weeks.
- Primary Outcome Measures
Name Time Method Sustained response 6 months 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.
- Secondary Outcome Measures
Name Time Method Complete remission 6 months The number of participants (responders) with platelet count\>=100x10\^9/L (CR) and the absence of bleeding.
Incidence of treatment-emergent adverse events 6 months Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time to response 6 months Time to response was defined as the time from starting treatment to the time to achieve the response.
Duration of response 6 months Duration of response was measured from the achievement of response to the loss of response.
Partial remission 6 months 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.
Trial Locations
- Locations (2)
Zhuo-Yu An
🇨🇳Beijing, China
Peking University Insititute of Hematology, Peking University People's Hospital
🇨🇳Beijing, China