Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Thrombocytopenia
Conditions
Keywords
ITP, rhTPO
Brief summary
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 .
Detailed description
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.
Interventions
DRUGrhTPO
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.
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Peking Union Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura). * Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy. * Two consecutive platelet counts (not in the same day) \< 30×10\^9/L. * Subject is willing and able to provide written informed consent.
Exclusion criteria
* Pregnancy or breast feeding. * Having a medical history of thrombosis. * Significant abnormal cardio-pulmonary function. * Abnormal liver and kidney function: * a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl); * a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range. * a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range. * Synchronous tumor. * Cannot adopt adequate contraceptive precautions during the course of the study. * Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ). * Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L) | up to 16 weeks per subject |
Secondary
| Measure | Time frame |
|---|---|
| The effective rate of maintenance treatments adopting different frequency of administration | up to 16 weeks per subject |
| Number of subjects with Adverse Events as a Measure of Safety | up to 18 weeks per subject |
Countries
China
Contacts
Primary ContactYongqiang Zhao, Dr.
Backup ContactShujie Wang
Outcome results
None listed