Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Phase 3

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Platelet Concentrate; Drug: recombinant human thrombopoietin

• Registration Number: NCT03492515
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study First Submitted: 2018-03-26
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-07
• Last Update Submitted: 2018-04-07
• Study First Posted: 2018-04-10
• Last Update Posted: 2018-04-10
• Study Start: 2018-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-administered group	Platelet Concentrate	No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions.
experimental group	recombinant human thrombopoietin	Accepting the treatment of rhTPO according platelet and bleeding condition

Primary Outcome Measures

Name	Time	Method
Platelet count during delivery	up to 2 years per subject	Platelet count during delivery will be assessed

Secondary Outcome Measures

Name	Time	Method
Adverse events in neonates	up to 2 years per subject	The number and frequency of therapy associated adverse events in neonates
platlet count of newborns	up to 42 days per newborn	Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs.
Adverse events in parturients	up to 2 years per subject	The number and frequency of therapy associated adverse events in parturients

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China