Overview

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.