Combined Steroid and Cyclosporin as First-line Treatment in Adults With Primary Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2025-07-20
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of cyclosporin plus standard steroid compared to standard steroid monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

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

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Cyclosporine; Cyclosporins; Prednisone

Criteria

Inclusion Criteria:

1. Newly-diagnosed, treatment-naive primary ITP;

2. Platelet counts <30×10^9/L;

3. Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);

3. Received first-line and second-line ITP specific treatments (e.g., steroids, intravenous immunoglobulin, TPO-RAs, rhTPO, rituximab, etc);

4. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);

5. Severe medical condition (lung, heart, hepatic or renal disorder);

6. Patients who are deemed unsuitable for the study by the investigator.