Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Romiplostim: 250 mcg of deliverable Romiplostim Lyophilized Powder for Solution for Injection in single dose vials will be supplied for subcutaneous administration once a week for 12 we
Sponsors
Levim Lifetech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be enrolled in the study if they meet all the following criteria 1. Male and female subjects of age group 18 to 65 years (both inclusive). 2. Willing and able to provide a written informed consent. 3. Diagnosed with ITP based on the American Society of Haematology (ASH) guidelines. 4. Already received at least one prior treatment for ITP. 5. Subject greater than 60 years of age must have had a documented history of ITP with a confirmatory bone marrow report on the diagnosis. 6. Two weekly platelet count less than or equal to 30 X 10 to the power of 9 per L at any time during the screening period. 7. Haemoglobin greater than or equal to 9.0 g per decilitre 8. Patients who are willing and able to comply with all the study assessments and adhere to the protocol schedule.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study participation if they fall on any of the below criteria 1. Known history or presence of hypersensitivity reaction to any recombinant E.coli derived products. 2. History of haematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell carcinoma 3. Known history of congenital thrombocytopenia, thromboembolic disease, systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia, antiphospholipid antibody syndrome or positive for lupus anticoagulant or autoimmune haemolytic anaemia 4. Known history of disseminated intravascular coagulation, haemolytic uremic syndrome, or thrombotic thrombocytopenic purpura. 5. Previous use of Romiplostim/ pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), TPO-RA drugs such as Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent 6. Currently receiving any treatment for ITP except corticosteroids, azathioprine, mycophenolate, cyclosporin, vincristine, and/or danazol administered at a constant dose and schedule. 7. 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. 8. 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. 9. Subjects with positive laboratory findings of hepatitis B, hepatitis C, or human immunodeficiency virus at screening 10. Known history of infection with H. pylori Known case of chronic liver disease or hepatic impairment, defined as any serum bilirubin greater than or equal to 1.5 times laboratory normal range at screening 11. 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 before randomization 12. Female subjects of child-bearing potential not using adequate contraceptive precautions in the judgement of the investigator 13. Breast-feeding mothers or female subjects of child-bearing potential with positive urine pregnancy test at the time of screening 14. Less than 2 months since major surgery 15. Subjects involved in clinical trials and taken investigational drugs within 30 days of enrolment 16. Creatinine clearance or calculated creatinine clearance less than 45 mL per minute (Cockcroft-Gault Equation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving platelet response (i.e., greater than or equal to 50 X 10 to the power of 9 per L) for any 4 weeks of the 12 weeks of treatment with biosimilar Romiplostim treatment compared to NplateTimepoint: 12 weeks (Every week including baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients receiving rescue medications that is Corticosteroids, IVIG, Anti D immunoglobulin, Platelet transfusions etc. during the treatment period, compared to Nplate Number of weekly Platelet Responses defined as a platelet count of greater than or equal to 50 X 10 to the power of 9 per L on the weekly scheduled dose day from week 1 to week 12 inclusive compared to Nplate Presence of Anti-Romiplostim Antibodies, compared to Nplate Incidence of Treatment-Emergent Adverse Events TEAEs & Serious Adverse Events SAEs during the treatment period related to biosimilar Romiplostim or Nplate Clinical chemistry, haematology, urine analysis & other laboratory findings during the 13 weeks, compared to Nplate. Single-dose pharmacokinetic PK parameters AUC0-t Cmax & Tmax of Romiplostim biosimilar compared to NplateTimepoint: Platelet Responses - Every week (Including baseline). Presence of Anti-Romiplostim Antibodies - baseline & week 13. Pharmacokinetic parameters - Week 2 to Week 11 (At 3 mcg/kg dose) | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed