A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy
Overview
- Phase
- Phase 3
- Intervention
- rhTPO
- Conditions
- Immune Thrombocytopenia
- Sponsor
- Shandong University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Early response 1- Response rate (CR+R)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Ming Hou
Professor and Director
Shandong University
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.
Arms & Interventions
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: rhTPO
Outcomes
Primary Outcomes
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.
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.
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.
Safety (Adverse events)
Time Frame: 6 months after delivery
Adverse events in patients and infants.