The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy

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

Details

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

Criteria

Inclusion Criteria:

1. Age 18-49;

2. Gestational weeks ≥20 weeks;

3. Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;

4. Confirmed diagnosed, treatment-naive ITP in pregnancy;

5. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Secondary ITP such as drug-related thrombocytopenia;

2. Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;

3. Severe immunodeficiency;

4. Myelodysplastic or myeloid fibrosis;

5. History of malignancy.