Status:
UNKNOWN
The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief 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 thrombocytope...
Detailed Description
The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy g...
Eligibility Criteria
Inclusion
- Age 18-49;
- Gestational weeks ≥20 weeks;
- Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms;
- Confirmed diagnosed, treatment-naive ITP in pregnancy;
- Willing and able to sign written informed consent.
Exclusion
- Secondary ITP such as drug-related thrombocytopenia;
- 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;
- Severe immunodeficiency;
- Myelodysplastic or myeloid fibrosis;
- History of malignancy.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05333744
Start Date
June 1 2021
End Date
September 1 2022
Last Update
April 19 2022
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China