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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02391272
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
The Affiliated Hospital of Qingdao University
The Second Hospital of Hebei Medical University
Institute of Hematology & Blood Diseases Hospital
Southern Medical University, China
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 20, 2020
Study Start Date  ICMJE March 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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.
  • Early response 2- Response rate (CR+R) [ Time Frame: 14th day ]
    Response rate (CR+R) at the 14th day.
  • Long-time response 1 (Platelet count) [ Time Frame: 10th week ]
    Platelet count at 10th week.
  • Long-time response 2 (Platelet count) [ Time Frame: 40 weeks' gestation ]
    Platelet count at 40 weeks' gestation.
  • Long-time response 3 (Platelet count) [ Time Frame: one month after delivery ]
    Platelet count one month after delivery.
  • Safety (Adverse events) [ Time Frame: 6 months after delivery ]
    Adverse events in patients and infants.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
Official Title  ICMJE A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Immune Thrombocytopenia
  • Pregnancy
Intervention  ICMJE Drug: rhTPO
Other Name: TPIAO
Study Arms  ICMJE 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.
Intervention: Drug: rhTPO
Publications * Kong Z, Qin P, Xiao S, Zhou H, Li H, Yang R, Liu X, Luo J, Li Z, Ji G, Cui Z, Bai Y, Wu Y, Shao L, Peng J, Ma J, Hou M. A novel recombinant human thrombopoietin therapy for the management of immune thrombocytopenia in pregnancy. Blood. 2017 Aug 31;130(9):1097-1103. doi: 10.1182/blood-2017-01-761262. Epub 2017 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
30
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02391272
Other Study ID Numbers  ICMJE ITP-pregnancy-rhTPO-Multi
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming Hou, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE
  • The Affiliated Hospital of Qingdao University
  • The Second Hospital of Hebei Medical University
  • Institute of Hematology & Blood Diseases Hospital
  • Southern Medical University, China
Investigators  ICMJE
Principal Investigator: Ming Hou, MD PhD Shandong University Qilu hospital
PRS Account Shandong University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP