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

March 19, 2020 updated by: Ming Hou, Shandong University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 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 cardiac arrhythmia)
  5. 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.
  6. Patients who are deemed unsuitable for the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhTPO
rhTPO will be given 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.
Drug: rhTPO
Other Names:
  • TPIAO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7th day
Early response 2- Response rate (CR+R)
Time Frame: 14th day
Response rate (CR+R) at the 14th day.
14th day
Long-time response 1 (Platelet count)
Time Frame: 10th week
Platelet count at 10th week.
10th week
Long-time response 2 (Platelet count)
Time Frame: 40 weeks' gestation
Platelet count at 40 weeks' gestation.
40 weeks' gestation
Long-time response 3 (Platelet count)
Time Frame: one month after delivery
Platelet count one month after delivery.
one month after delivery
Safety (Adverse events)
Time Frame: 6 months after delivery
Adverse events in patients and infants.
6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

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

Investigators

  • Principal Investigator: Ming Hou, MD PhD, Shandong University Qilu Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-pregnancy-rhTPO-Multi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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