Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

• ClinicalTrials.gov Identifier: NCT03492515
• Recruitment Status: Not yet recruiting
• First Posted: April 10, 2018
• Last Update Posted: April 10, 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
• Information provided by (Responsible Party): Ming Hou, Shandong University

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.

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenia	Drug: recombinant human thrombopoietin; Drug: Platelet Concentrate	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Clinical Study of Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia
• Estimated Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 1, 2020
• Estimated Study Completion Date: May 1, 2022

Arms and Interventions

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 Name: 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。

Outcome Measures

Primary Outcome Measures :

1. Platelet count during delivery [ Time Frame: up to 2 years per subject ]
   Platelet count during delivery will be assessed

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Ming Hou, Dr; +86-531-82169114 ext 9879; houming@medmail.com.cn

Locations

China, Shandong

Qilu hospital, Shandong University

Jinan, Shandong, China, 250012

Sponsors and Collaborators

Shandong University

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

Investigators

• Principal Investigator: Ming Hou,, Dr; Shandong University

More Information

• Responsible Party: Ming Hou, Professor and Director, Shandong University
• ClinicalTrials.gov Identifier: NCT03492515 History of Changes
• Other Study ID Numbers: rhTPO in pregnancy of ITP
• First Posted: April 10, 2018
• Last Update Posted: April 10, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Hou, Shandong University:

immune thrombocytopenia

Additional relevant MeSH terms:

Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Blood Platelet Disorders; Hematologic Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Signs and Symptoms