Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Study Overview
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Brief Summary
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The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.

Detailed Description
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The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.

Official Title
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A Multicenter Clinical Study of Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: recombinant human thrombopoietin
* Drug: Platelet Concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. 18-50 years of age; gestational age over 32 weeks; No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted); Platelet transfusion was not effective. Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding. No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin ); No severe cardiac and pulmonary dysfunction; No history of mental illness; Voluntarily signed written informed consent. Exclusion Criteria: A history of serious allergies to biologics; The history of thrombosis; Thromboembolic or hemorrhagic disease; Patients who are deemed unsuitable for the study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: experimental group<br>Accepting the treatment of rhTPO according platelet and bleeding condition | Drug: recombinant human thrombopoietin<br>* If platelet count <30×10^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count <30×10^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment.<br>* Other names: rhTPO;|
| Active Comparator: non-administered group<br>No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions. | Drug: Platelet Concentrate<br>* according to the their conditions, use if necessary<br>|
| No Intervention: healthy control group<br>Healthy pregnant women and no use of any medicine。 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count during delivery | Platelet count during delivery will be assessed | up to 2 years per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in neonates | The number and frequency of therapy associated adverse events in neonates | up to 2 years per subject | 
| platlet count of newborns | Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs. | up to 42 days per newborn | 
| Adverse events in parturients | The number and frequency of therapy associated adverse events in parturients | up to 2 years per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune thrombocytopenia