Immune Thrombocytopenia Clinical Trial
Official title:
A Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)
The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
The investigators are undertaking a parallel group, multicentre, randomised controlled trial
of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly
assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients)
will receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in
group B will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7
times.The patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7
consecutive days .All the patients will follow with a flexible dosage depending on platelet
count during the following 12 weeks.
Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in
order to evaluate the efficacy and safety of different dose and frequency Recombinant Human
thrombopoietin in treating the primary immune thrombocytopenia (ITP)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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