Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

Last updated: April 7, 2018
Sponsor: Shandong University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dysfunctional Uterine Bleeding

Thrombosis

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

N/A

Clinical Study ID

NCT03492515
rhTPO in pregnancy of ITP
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 (astable 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 thannormal 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

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

Total Participants: 90
Study Start date:
May 01, 2018
Estimated Completion Date:
May 01, 2022

Study 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.

Connect with a study center

  • Qilu hospital, Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

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