Thrombocytopenia Clinical Trial
Official title:
A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia
The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once
daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in
the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for
12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every
other day followed by the interval adjustments for keeping platelet counts between 30
×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up
for 4 weeks after maintenance treatment.
Platelet count, bleeding and other symptoms will be evaluated before and after treatment.
Platelet transfusion will be administered to subjects with active bleeding symptoms.
Toxicity will be monitored continuously during the entire study. Safety will be assessed by
adverse events and laboratory tests.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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