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

NCT ID: NCT02391272


Title
A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy
Purpose
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.
Details
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.
Conditions
Immune Thrombocytopenia, Pregnancy
Keywords
recombinant human thrombopoietin, immune thrombocytopenia, pregnancy
Source
Shandong University
Sponsors
Shandong University, Qingdao University, The Second Hospital of Hebei Medical University, Institute of Hematology & Blood Diseases Hospital, Southern Medical University, China
Status
Recruiting
Acronym
Last Updated
17 Apr 2016
URL
Official Link
Locations
China