About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Iguratimod
- low-dose rituximab
Treatment groups
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Beijing Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Navy General Hospital, Beijing
Collaborator
Beijing Tongren Hospital
Collaborator