Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03492515
• Other study ID #: rhTPO in pregnancy of ITP
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 26, 2018
• Last updated: April 7, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2018
• Source: Shandong University
• Contact: Ming Hou, Dr
• Phone: +86-531-82169114
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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.
• Platelet Concentrate
according to the their conditions, use if necessary

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (7)

Lead Sponsor	Collaborator
Shandong University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count during delivery	Platelet count during delivery will be assessed	up to 2 years per subject
Secondary	Adverse events in neonates	The number and frequency of therapy associated adverse events in neonates	up to 2 years per subject
Secondary	platlet count of newborns	Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs.	up to 42 days per newborn
Secondary	Adverse events in parturients	The number and frequency of therapy associated adverse events in parturients	up to 2 years per subject