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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Prednisone
* Drug: Recombinant Human TPO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone plus rhTPO<br>Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks | Drug: Prednisone<br>* Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal.<br>Drug: Recombinant Human TPO<br>* rhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal.<br>* Other names: rhTPO;|
| Active Comparator: Prednisone<br>Prednisone 20mg per day, 2 weeks | Drug: Prednisone<br>* Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding. | day 14 | 
| Platelet counts at delivery | Platelet counts at delivery | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bleeding | Number of patients with bleeding symptome | During treatment（up to 6 weeks after delivery） | 
| Number of patients with adverse events | Number of patients with adverse events | During treatment（up to 6 weeks after delivery） | 
| Platelet counts of newborns | Platelet counts of newborns | at delivery | 
| Number of newborns with adverse events | Number of newborns with adverse events | During treatment（up to 6 weeks after delivery） | 
| Loss of response | Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R) | During treatment（up to 6 weeks after delivery） |