Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

NCT ID: NCT03492515

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Accepting the treatment of rhTPO according platelet and bleeding condition

Group Type: EXPERIMENTAL

recombinant human thrombopoietin

Intervention Type: DRUG

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.

non-administered group

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

Group Type: ACTIVE_COMPARATOR

Platelet Concentrate

Intervention Type: DRUG

according to the their conditions, use if necessary

healthy control group

Healthy pregnant women and no use of any medicine。

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Platelet Concentrate

according to the their conditions, use if necessary

Intervention Type: DRUG

Other Intervention Names

rhTPO

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Zhongshan Bo Ai Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou,, Dr

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

Qilu hospital, Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Ming Hou, Dr

Role: CONTACT

houming@medmail.com.cn

+86-531-82169114 ext. 9879

Other Identifiers

rhTPO in pregnancy of ITP

Identifier Type: -

Identifier Source: org_study_id