NCT03492515

Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
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.
DRUG	Platelet Concentrate	according to the their conditions, use if necessary

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-05-01
• Completion: 2022-05-01
• First posted: 2018-04-10
• Last updated: 2018-04-10

Locations

1 site across 1 country: China