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Completed

NCT Number: NCT02391272

A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, China

About this study

The investigators are undertaking a multicenter, open-labeled, pilot study of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University and other well-known hospitals in China. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is between 18-50 years old.
  • After 12 weeks gestation.
  • Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
  • Patients who have no response or relapsed after Corticosteroid or IVIG.
  • Patients developed refractoriness to platelet transfusion.
  • To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  • Willing and able to sign written informed consent.

Exclusion criteria

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  • Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  • 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 cardiac arrhythmia)
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  • Patients who are deemed unsuitable for the study by the investigator.

Treatment and study plan

rhTPO

Drug

Other names: TPIAO

Primary outcomes

  1. Early response 1- Response rate (CR+R)

    Time frame: 7th day

    Response rate (CR+R) at the 7th day. CR is defined as platelet count ≥ 100×10^9/L, and R is defined as platelet count of >30×10^9/L with at least a doubling of the baseline value.

  2. Early response 2- Response rate (CR+R)

    Time frame: 14th day

    Response rate (CR+R) at the 14th day.

  3. Long-time response 1 (Platelet count)

    Time frame: 10th week

    Platelet count at 10th week.

  4. Long-time response 2 (Platelet count)

    Time frame: 40 weeks' gestation

    Platelet count at 40 weeks' gestation.

  5. Long-time response 3 (Platelet count)

    Time frame: one month after delivery

    Platelet count one month after delivery.

  6. Safety (Adverse events)

    Time frame: 6 months after delivery

    Adverse events in patients and infants.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China
  • Southern Medical University, China
  • The Affiliated Hospital of Qingdao University
  • The Second Hospital of Hebei Medical University

Registry information

Official study title

A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 18, 2015
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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