Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

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

120 Participants
are divided into 2 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