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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Collaborators: Institute of Hematology & Blood Diseases Hospital; Qingdao University; Southern Medical University, China; The Affiliated Hospital of Qingdao University; The Second Hospital of Hebei Medical University

Criteria

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.