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Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT03492515
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
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

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.

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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


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。



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492515


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

Locations
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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
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Principal Investigator: Ming Hou,, Dr Shandong University

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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    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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