Overview

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.