Chronic Idiopatic Thrombocytopenic Purpura(ITP)
Conditions
Interventions
Placebo Group:Placebo
Romiplostim for injection Group:Romiplostim for injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with ITP for at least 6 months prior to signing the ICF; 2. Subject is >=18 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 no response or relapse to at least 1 prior treatment for ITP; 4. 3 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. Subjects fully understand and comply with the study protocol requirements and voluntarily sign the informed consent form.
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); history of venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy; 4. Documented history of Cardiovascular disease (grade III/IV congestive heart failure, arrhythmia or angina, unstable angina, and had coronary artery carotid stenting and angioplasty or coronary artery bypass grafting); 5. Documented diagnosis of anti-phospholipid antibody syndrome and other autoimmune diseases (e.g., systemic lupus erythematosus); 6. Received glucocorticoids treatment within 4 weeks and any other medicines for ITP treatment within 2 weeks prior to signing the ICF, excluding the subjects with stable dosage treatment more than 4 weeks (adrenocorticosteroid, azathioprine or , danazol , cyclosporin A and mycophenolate mofetil); 7. Had a splenectomy for any reason within 12 weeks prior to signing the ICF; 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 MPL stimulation product other than the subject who had suspended recombinant human thrombopoietin (rHuTPO or Romiplostim for injection for 4 weeks before signing ICF; 10. 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; 11. Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF; 12. 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; 13. Pregnant or breastfeeding; 14. Subjects of reproductive potential not using adequate contraceptive precautions; 15. Known severe drug hypersensitivity; 16. In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial; 17. The laboratory blood coagulation tests show that the prothrombin time (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 to increase PLT count, excluding vitamin or mineral supplements, within 1 week prior to signing the ICF; 19. The subject with positive for HCV or HIV test. The subjects with HBsAg positive and DNA copy number of HBV greater than 1000cps/ML.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of weeks in which the platelet response (platelet counts increase above 50*10^9/L as measured on each week prior to administration) takes place during the comparative trial period (Week 2-7).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose platelet counts relative to the baseline* increase >=20*10^9/L during the comparative trial period;Proportion of subjects who have received emergency treatment to increase the platelet counts during the comparative trial period.;Proportion of subjects whose platelet counts are >=100*10^9/L and without bleeding symptom in each week.;Proportion of subjects whose platelet counts relative to the baseline* increase more than 2 times and reached more than 30*10^9/L and without bleeding symptom in each week.;Shifting of the platelet counts in each week.;Proportion of subjects whose platelet counts have increased by >=20*10^9/L relative to the baseline* in each week.;Proportion of subjects whose platelet counts >=50*10^9/L in each week;Proportion of subjects who have received emergency treatment to increase the platelet counts;Safety evaluation:incidence of adverse events, evaluation of anti-TPO antibody and anti-Romiplostim antibody, vital signs and laboratory values.; | — |
Countries
China
Contacts
Public ContactZhao Yongqiang
Outcome results
None listed