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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
Sponsor
Peking University People's Hospital
Phase
Phase 2
Started
2025-07-01
Last updated
2025-07-10

Condition(s) studied

Immune Thrombocytopenia (ITP)

Investigational drug(s) / intervention(s)

Iguratimodlow-dose rituximab

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
Peking University Insititute of Hematology Beijing China
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