Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Romiplostim Powder and Solvent for Solution for Injection of Intas Pharmaceuticals Limited: Dose: 3.00 mcg/kg
Duration of treatment: Single dose
Control Intervention1: Romiplostim Powder and Solvent for Solution for Injection of Amgen Inc: Dose: 3.00 mcg/kg
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients aged between 18 to 65 years (both inclusive) 2. Patients in good health as determined by past medical history, physical examination, vital signs (Heart rate, blood pressure, respiratory rate and oral body temperature), ECG and laboratory tests at screening 3. Subject must weigh at least 50 kg to participate in the study and must have body mass index (BMI) within the range of 18-30 kg/m2 4. Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 3months before enrolment 5. Have completed at least 1 prior treatment for ITP 6. Subject (or legally acceptable representative) is willing and able to provide written informed consent 7. Patient must be able to communicate well with the investigator, adhere to the study visit schedule, understand and comply with all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Previously patients have taken romiplostim during last one year 2. History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder. 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. Pregnant or breast feeding 9. Use of other investigational drug at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer 10. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 11. Nursing (lactating) women 12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means unless they are using acceptable methods of contraception 13. Fertile males, defined as all males physiologically capable of conceiving offspring unless the subjects agrees to comply with effective contraceptive methods for the entire duration and refrain from fathering a child for at least 3 months following last study drug administration 14. Smokers (use of tobacco products in the previous 3 months) 15. Use of any prescription drugs, herbal supplements which are known to interfere with pharmacokinetics or pharmacodynamics of romiplostim 16. Donation or loss of 400 ml or more of blood or equivalent plasma within 8 weeks prior to initial dosing or longer if required by local regulation 17. Significant illness within 2 weeks prior to initial dosing 18. History of immunodeficiency diseases including a positive HIV test result. A positive HBsAg or Hepatitis C test results 19. Any other condition that in the opinion of investigator could hamper participation in the study 20. History of drug or alcohol abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during screening and/or baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of pharmacokinetic parameters of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. in chronic refractory immune (idiopathic) thrombocytopenic purpura patientsTimepoint: Visit 2 to visit 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment safety and tolerability of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc 2. Assessment of pharmacodynamics of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc.Timepoint: Visit 1 to Visit 10 | — |
Countries
India
Contacts
Public ContactMr Sumanta Nandi
Lambda Therapeutic Research Ltd
Outcome results
None listed