Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Romiplostim Powder and Solvent for Solution for Injection: Dose:250 & 500 mcg Lyophilized Powder vial, Frequency: Once in a week,
Mode of Administration: Subcutaneous, Duration of treat
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients aged between 18 to 65 years (both inclusive) 2. Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 12months before enrolment4 3. Have completed at least 1 prior treatment for ITP 4. Value of platelet count must be: (i) less than 30000/μL for those patients not receiving any ITP therapy (ii) less than 50000/μL for those patients receiving a constant dose schedule of corticosteroids 5. Written informed and signed consent 6. Patient must be able to adhere to the study visit schedule, understand, and comply with all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder 2. Positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus 3. Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit 4. Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc) within 1 week before the screening visit 5. Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening visit 6. Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study 7. Less than 2 months since major surgery 8. Any other condition that in the opinion of investigator could hamper participation in the study 9. Previous participation in any clinical trial within 1 month before the entry of the study 10. Pregnant or breast feeding 11. Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving platelet response (Platelet response is defined as a platelet count at a scheduled weekly visit of 50000/μL or more and double the platelet count from baseline in the absence of rescue medication within the 8 weeks.)Timepoint: Baseline to week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Dose required to achieve targeted platelet count (50000/μL) â?¢Proportion of patients with at least one dose increment â?¢Proportion of patients with at least one dose reduction â?¢Patients having Platelet count â?¥400000/ μLTimepoint: Baseline to week 8 | — |
Countries
India
Contacts
Public ContactDr Ravi Panchal
Lambda Therapeutic Research Ltd
Outcome results
None listed