Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2023-12-12
• Target enrollment: 0
• Participant gender: All

Summary

A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital

Criteria

Inclusion Criteria:

• Primary immune thrombocytopenia (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;

• 18 years older;

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

• Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.