Trial | NCT03492515  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    90
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 Started
May 01
2018
Anticipated
Primary Completion
May 01
2020
Anticipated
Study Completion
May 01
2022
Anticipated
Last Update
Apr 10
2018

Drug recombinant human thrombopoietin

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.

  • Other names: rhTPO

Drug Platelet Concentrate

according to the their conditions, use if necessary

experimental group Experimental

Accepting the treatment of rhTPO according platelet and bleeding condition

non-administered group Active Comparator

No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions.

healthy control group No Intervention

Healthy pregnant women and no use of any medicine。

Criteria 

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.
No Results Posted