Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Recombinant Human Thrombopoietin (rhTPO) injection: Recombinant Human Thrombopoietin (rhTPO) injection, will be administered subcutaneously at 1.0 µg/kg (300U/kg) once daily for 14 days
Sponsors
Eris Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female, aged 18 to 65 years old 2. Meeting the following criteria of ITP: a. Thrombocytopenia by repeated lab tests. b. Bone marrow examination shows megakaryocyte count increasing or at normal level with dysmaturity. 3. Patients with Platelet count = 20×109/L at any time during the screening period, who are non-responsive to standard or high-dose glucocorticoids. 4. Patients without splenectomy. 5. Patients willing to give written validinformed and signed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or patients not willing to adopt contraceptive measures during the trial. 2. Patient with Thrombosis history. 3. Patients with a diagnosis of secondary thrombocytopenia. 4. Patients with hepatorenal dysfunction (serum transaminase and bilirubin are over 1.5 folds of normal upper limit, and creatinine =1.5mg/dl). 5. Patients with severe cardiorespiratory dysfunction. 6. Patients who have active malignancy. 7. Patient with hypersensitivity to study drug or any of its excipients. 8. Patients on other thrombopoietin receptor agonists (Eltrombopag) as they compete with TPIAO for TPO receptor binding. 9. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 10.Patients with suspected inability to comply with the study procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Compare the complete response rate; Platelet count = 100 X 109 /L and absence of bleeding between two groups. 2. Compare the response rate ;Platelet count between = 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups 3.Compare the total response rate between two groups.Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Compare the maximum value and increment in platelet count between two groups 2.Compare the frequencies and total volume of platelet transfusion between two groups 3.Observe the time of platelet count to complete response (reaching =100×109/L) and maintenance duration.Timepoint: 14 days;4.Occurrence of non neutralizing or neutralizing TPO antibodies.Timepoint: 28 days;5.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parametersTimepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Eris Lifesciences Ltd
Outcome results
None listed