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Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

recombinant human thrombopoietin

Platelet Concentrate

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring immune thrombocytopenia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
18-50 years of age; gestational age over 32 weeks;
No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
Platelet transfusion was not effective.
Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding.
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 );
No severe cardiac and pulmonary dysfunction;
No history of mental illness;
Voluntarily signed written informed consent.

Exclusion Criteria:

A history of serious allergies to biologics;
The history of thrombosis;
Thromboembolic or hemorrhagic disease;
Patients who are deemed unsuitable for the study by the investigator.

Sites / Locations

Qilu hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

experimental group

non-administered group

healthy control group

Arm Description

Accepting the treatment of rhTPO according platelet and bleeding condition

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

Healthy pregnant women and no use of any medicine。

Outcomes

Primary Outcome Measures

Platelet count during delivery

Platelet count during delivery will be assessed

Secondary Outcome Measures

Adverse events in neonates

The number and frequency of therapy associated adverse events in neonates

platlet count of newborns

Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs.

Adverse events in parturients

The number and frequency of therapy associated adverse events in parturients

Full Information

NCT ID

NCT03492515

First Posted

March 26, 2018

Last Updated

April 7, 2018

Sponsor

Shandong University

Collaborators

Peking University People's Hospital, First Affiliated Hospital of Chongqing Medical University, Linyi People's Hospital, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital, Zhongshan Bo Ai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03492515

Brief Title

Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Anticipated)

Primary Completion Date

May 1, 2020 (Anticipated)

Study Completion Date

May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

Keywords

immune thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Accepting the treatment of rhTPO according platelet and bleeding condition

Arm Title

non-administered group

Arm Type

Active Comparator

Arm Description

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

Arm Title

healthy control group

Arm Type

No Intervention

Arm Description

Healthy pregnant women and no use of any medicine。

Intervention Type

Drug

Intervention Name(s)

recombinant human thrombopoietin

Other Intervention Name(s)

rhTPO

Intervention Description

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

Intervention Name(s)

Platelet Concentrate

Intervention Description

according to the their conditions, use if necessary

Primary Outcome Measure Information:

Title

Platelet count during delivery

Description

Platelet count during delivery will be assessed

Time Frame

up to 2 years per subject

Secondary Outcome Measure Information:

Title

Adverse events in neonates

Description

The number and frequency of therapy associated adverse events in neonates

Time Frame

up to 2 years per subject

Title

platlet count of newborns

Description

Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs.

Time Frame

up to 42 days per newborn

Title

Adverse events in parturients

Description

The number and frequency of therapy associated adverse events in parturients

Time Frame

up to 2 years per subject

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. 18-50 years of age; gestational age over 32 weeks; No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted); Platelet transfusion was not effective. Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding. 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 ); No severe cardiac and pulmonary dysfunction; No history of mental illness; Voluntarily signed written informed consent. Exclusion Criteria: A history of serious allergies to biologics; The history of thrombosis; Thromboembolic or hemorrhagic disease; Patients who are deemed unsuitable for the study by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou, Dr

Phone

+86-531-82169114

Ext

9879

houming@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou,, Dr

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

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