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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Qilu Hospital, Shandong University
Jinan, Shandong, China
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.
Time frame: 7th day
Early response 2- Response rate (CR+R)
Response rate (CR+R) at the 14th day.
Time frame: 14th day
Long-time response 1 (Platelet count)
Platelet count at 10th week.
Time frame: 10th week
Long-time response 2 (Platelet count)
Platelet count at 40 weeks' gestation.
Time frame: 40 weeks' gestation
Long-time response 3 (Platelet count)
Platelet count one month after delivery.
Time frame: one month after delivery
Safety (Adverse events)
Adverse events in patients and infants.
Time frame: 6 months after delivery
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