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

Peking University

Status and phase

Unknown

Phase 2

Conditions

Immune Thrombocytopenia

Treatments

Drug: Iguratimod

Study type

Interventional

Funder types

Other

Identifiers

NCT05302024

I-ITP 001

Details and patient eligibility

About

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)

Full description

The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.