Status:
UNKNOWN
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
Lead Sponsor:
Shandong University
Conditions:
Immune Thrombocytopenia
Pregnancy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02270801
Start Date
October 1 2014
End Date
April 1 2017
Last Update
April 20 2016
Active Locations (1)
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1
Shandong University Qilu hospital
Jinan, Shandong, China, 250012