Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy

Last updated: April 18, 2016
Sponsor: Shandong University
Overall Status: Trial Status Unknown

Phase

3

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Pregnancy

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

N/A

Clinical Study ID

NCT02270801
rhTPO-ITP-Pregnancy
  • Ages 18-50
  • Female

Study Summary

This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is between 18-50 years old.

  2. After 12 weeks gestation.

  3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.

  4. Patients who have no response or relapsed after Corticosteroid or IVIG.

  5. Patients developed refractoriness to platelet transfusion.

  6. To show a platelet count < 30×10^9/L, and with bleeding manifestations.

  7. Willing and able to sign written informed consent.

Exclusion

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet countswithin 3 months before the screening visit.

  2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine,vincristine, vinblastine, etc) within 3 months before the screening visit.

  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

  4. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiacarrhythmia)

  5. Have a known diagnosis of other autoimmune diseases, established in the medicalhistory and laboratory findings with positive results for the determination ofantinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or directCoombs test.

  6. Patients who are deemed unsuitable for the study by the investigator.

Study Design

Total Participants: 30
Study Start date:
October 01, 2014
Estimated Completion Date:
April 30, 2017

Study Description

The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Connect with a study center

  • Shandong University Qilu hospital

    Jinan, Shandong 250012
    China

    Active - Recruiting

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