Clinical Trials in China / NCT07057778
Starting soon
Phase 2
Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
NCT07057778 · tracked via the Priya Life Science China tracker
Condition(s) studied
Immune Thrombocytopenia (ITP)
Investigational drug(s) / intervention(s)
Iguratimod: oral iguratimod at 25mg twice daily for 26 weeks
low-dose rituximab: rituximab 100mg once weekly for 6 weeks
Study summary
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
Eligibility
Inclusion Criteria:
* 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;
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;
* Patients with other diseases were undergoing treatment with immunosuppressants;
* Patients with ITP had received rituximab;
Primary outcome measure(s)
- overall response — From the start of study treatment (Day 1) up to the end of Year 1
The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Insititute of Hematology | Beijing | China |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07057778 on ClinicalTrials.gov ↗ ← All trials in China