Back to resultsA Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
Primary Purpose
Immune Thrombocytopenia, Pregnancy
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhTPO
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring recombinant human thrombopoietin, immune thrombocytopenia, pregnancy
Eligibility Criteria
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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rhTPO
Arm Description
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.
Outcomes
Primary Outcome Measures
Early response 1- Response rate (CR+R)
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)
Response rate (CR+R) at the 14th day.
Long-time response 1 (Platelet count)
Platelet count at 10th week.
Long-time response 2 (Platelet count)
Platelet count at 40 weeks' gestation.
Long-time response 3 (Platelet count)
Platelet count one month after delivery.
Safety (Adverse events)
Adverse events in patients and infants.
Secondary Outcome Measures
Full Information
NCT ID
NCT02391272
First Posted
March 2, 2015
Last Updated
March 19, 2020
Sponsor
Shandong University
Collaborators
The Affiliated Hospital of Qingdao University, The Second Hospital of Hebei Medical University, Institute of Hematology & Blood Diseases Hospital, China, Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02391272
Brief Title
A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
Official Title
A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
The Affiliated Hospital of Qingdao University, The Second Hospital of Hebei Medical University, Institute of Hematology & Blood Diseases Hospital, China, Southern Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia, Pregnancy
Keywords
recombinant human thrombopoietin, immune thrombocytopenia, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhTPO
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
rhTPO
Other Intervention Name(s)
TPIAO
Primary Outcome Measure Information:
Title
Early response 1- Response rate (CR+R)
Description
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.
Time Frame
7th day
Title
Early response 2- Response rate (CR+R)
Description
Response rate (CR+R) at the 14th day.
Time Frame
14th day
Title
Long-time response 1 (Platelet count)
Description
Platelet count at 10th week.
Time Frame
10th week
Title
Long-time response 2 (Platelet count)
Description
Platelet count at 40 weeks' gestation.
Time Frame
40 weeks' gestation
Title
Long-time response 3 (Platelet count)
Description
Platelet count one month after delivery.
Time Frame
one month after delivery
Title
Safety (Adverse events)
Description
Adverse events in patients and infants.
Time Frame
6 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, MD PhD
Organizational Affiliation
Shandong University Qilu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28630121
Citation
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.
Results Reference
derived
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A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
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