Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP
Recruitment status was: Recruiting
Idiopathic Thrombocytopenic Purpura
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L) [ Time Frame: up to 16 weeks per subject ] [ Designated as safety issue: No ]
- The effective rate of maintenance treatments adopting different frequency of administration [ Time Frame: up to 16 weeks per subject ] [ Designated as safety issue: No ]
- Number of subjects with Adverse Events as a Measure of Safety [ Time Frame: up to 18 weeks per subject ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active investigational product
Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805648
|Peking Union Medical College Hospital|
|Principal Investigator:||Yongqiang Zhao, Dr.||Peking Union Medical College|