Chronic Idiopatic Thrombocytopenic Purpura(ITP)
Conditions
Interventions
Group 1:Romiplostim: 1ug/kg
Group 2:Romiplostim: 3ug/kg
Group 3:Romiplostim: 6ug/kg
Sponsors
Chinese Academy of Medical Science Hematology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with ITP for at least 6 months prior to signing the ICF; 2. Subject to aged between 18 and 70 years old while signing the ICF; 3. Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded those subjects who have previously received rHuTPO or any other thrombopoietin receptor (MPL) agonist; 4. Three scheduled platelet counts taken during the screening period must be: =10 g/dL and absolute neutrophil count (ANC) >= 1.5*10^9/L; 7. A serum creatinine concentration taken during the screening period must be <=2 mg/dL (176.8umol/L). Adequate liver function, as evidenced by a serum bilirubin taken during the screening period <=1.5 times of the upper limit of the normal range, ALT and AST <=3 times of the upper limit of the normal range; 8. Before any study-specific procedure, the appropriate written informed consent must be obtained.
Exclusion criteria
Exclusion criteria: 1. Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than those typical of ITP; 2. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF; 3. Documented diagnosis of arterial thrombosis (e.g., cerebral thrombosis, transient ischemic attack, or myocardial infarction) in the previous year; history or concomitant of venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism). Receiving anticoagulation therapy or antiplatelet drug before screening; 4. Documented diagnosis of anti-phospholipid antibody syndrome and other autoimmune diseases (e.g., systemic lupus erythematosus); 5. Receiving glucocorticoid therapy (except oral glucocorticoids administered at a constant dose for more than 4 weeks at the first screening visit) within 4 weeks or the other treatment for ITP including emergency treatment within 2 weeks prior to signing the ICF; 6. Had a splenectomy for any reason within 12 weeks prior to signing the ICF; 7. Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other MPL stimulation product; 8. Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF; 9. Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, Interferon-alfa) for any reason within 8 weeks prior to signing the ICF; 10. Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF; 11. Less than 4 weeks since end of any clinical trials about therapeutic drug or device not CFDA-approved for any indication prior to signing the ICF; 12. Pregnant or breast feeding; 13. Subjects of reproductive potential who are not using adequate contraceptive precautions judged by investigators; 14. Known severe drug hypersensitivity; 15. Concerns for subject's compliance with the protocol; 16. In the opinions of the principal investigator or investigators, the patients are not suitable for participating in this trial; 17. The laboratory blood coagulation tests show that Prothrombin time-international normalized ratio(PT-INR)and activated partial thromboplastin time (APTT) exceed 20% of the normal reference range; except for ITP, there was past history of coagulation abnormalities; 18. Consumption of any herbal or dietary supplements aimed at increasing the PLT count, excluding vitamin or mineral supplements, within 1 week prior to signing the ICF; 19. The test results of hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies are positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation: The incidence of all adverse events including evaluation of antidrug antibody status.;Pharmacodynamics: To evaluate the platelet count of each time point post-administration, the peak platelet count, time to peak, absolute and fold change from baseline* to peak platelet count, absolute and fold change from baseline to Day 8, 11 and 15.;Pharmacokinetics: To evaluate the serum Romiplostim concentration and pharmacokinetic parameters.; | — |
Countries
China
Contacts
Public ContactYang Renchi
Outcome results
None listed