Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Shandong University90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia

Interventions

recombinant human thrombopoietinDRUG

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.

Platelet ConcentrateDRUG

according to the their conditions, use if necessary

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meet the diagnostic criteria for immune thrombocytopenia. 2. 18-50 years of age; gestational age over 32 weeks; 3. No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted); 4. Platelet transfusion was not effective. 5. Platlet count of the patients \<30\* 10\^9/L and had the risk of bleeding or bleeding. 6. 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 ); 7. No severe cardiac and pulmonary dysfunction; 8. No history of mental illness; 9. Voluntarily signed written informed consent. Exclusion Criteria: 1. A history of serious allergies to biologics; 2. The history of thrombosis; 3. Thromboembolic or hemorrhagic disease; 4. Patients who are deemed unsuitable for the study by the investigator.

Locations (1)

Qilu hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

Platelet count during delivery

Platelet count during delivery will be assessed

Time frame: up to 2 years per subject

Secondary Outcomes

Adverse events in neonates

The number and frequency of therapy associated adverse events in neonates

Time frame: 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.

Time frame: up to 42 days per newborn

Adverse events in parturients

The number and frequency of therapy associated adverse events in parturients

Time frame: up to 2 years per subject

Central Contacts

Ming Hou, Dr

CONTACT

+86-531-82169114 houming@medmail.com.cn

Data from ClinicalTrials.gov

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