Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: a Phase 2, Open-label, Single-arm Trial
Overview
- Phase
- Phase 2
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Durable response
Overview
Brief Summary
A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)
Detailed Description
The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- •Platelet count of less than 30×10\^9/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.
Arms & Interventions
Iguratimod treatment
Iguratimod is given at a dose of 25 mg bid for 12 weeks.
Intervention: Iguratimod (Drug)
Outcomes
Primary Outcomes
Durable response
Time Frame: 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.
Secondary Outcomes
- Remission(12 months)
- Bleeding(12 months)
- Initial response(1 month)
- Time to response(12 months)
- Adverse events(12 months)
Investigators
Xiao Hui Zhang
Vice president of Peking University Institute of Hematology
Peking University People's Hospital