Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

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

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

Study Overview

• Status: Unknown
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Drug: recombinant human thrombopoietin; Drug: Platelet Concentrate

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; Accepting the treatment of rhTPO according platelet and bleeding condition	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.; Other Names: rhTPO
ACTIVE_COMPARATOR: non-administered group; No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions.	Drug: Platelet Concentrate; according to the their conditions, use if necessary
NO_INTERVENTION: healthy control group; Healthy pregnant women and no use of any medicine。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet count during delivery	Platelet count during delivery will be assessed	up to 2 years per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events in neonates	The number and frequency of therapy associated adverse events in neonates	up to 2 years per subject
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
Adverse events in parturients	The number and frequency of therapy associated adverse events in parturients	up to 2 years per subject

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Peking University People's Hospital; The Affiliated Hospital of Qingdao University; Shandong Provincial Hospital; First Affiliated Hospital of Chongqing Medical University; Linyi People's Hospital; Zhongshan Bo Ai Hospital
• Investigators: Principal Investigator: Ming Hou,, Dr, Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 7, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 7, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: immune thrombocytopenia
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: rhTPO in pregnancy of ITP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No