Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Shandong University

Status and phase: Unknown; Phase 3

Conditions: Immune Thrombocytopenia

Treatments: Drug: Platelet Concentrate; Drug: recombinant human thrombopoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03492515

rhTPO in pregnancy of ITP

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

experimental group

Experimental group

Description:

Accepting the treatment of rhTPO according platelet and bleeding condition

Treatment:

Drug: recombinant human thrombopoietin

non-administered group

Active Comparator group

Description:

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

Treatment:

Drug: Platelet Concentrate

healthy control group

No Intervention group

Description:

Healthy pregnant women and no use of any medicine。