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

Peking University

Status and phase: Unknown; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Prednisone; Drug: Recombinant Human TPO

Study type: Interventional

Funder types: Other

Identifiers

NCT05333744

ITP-PKU2204

Details and patient eligibility

About

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

Full 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 group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Prednisone plus rhTPO

Experimental group

Description:

Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks

Treatment:

Drug: Prednisone

Drug: Recombinant Human TPO

Prednisone

Active Comparator group

Description:

Prednisone 20mg per day, 2 weeks

Treatment:

Drug: Prednisone