Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong University
• Collaborators: First Affiliated Hospital of Chongqing Medical University; Linyi People's Hospital; Peking University People's Hospital; Shandong Provincial Hospital; The Affiliated Hospital of Qingdao University; Zhongshan Bo Ai Hospital

Criteria

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.