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

Locations

1
Peking University Insititute of Hematology Beijing China

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