Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: ENZ110 (similar biologic of Romiplostim): Single-use vials contain 250 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder.
Control Intervention1: Innovator Rom
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female subject in between 18 to 65 years of age 2. Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines (APPENDIX I) 3. If Subject is > 60 years of age, subject has a written bone marrow biopsy report consistent with a diagnosis of ITP 4. Subject has received at least 1 prior therapy for ITP 5. Subject with a single platelet count � 30 x 10�/L at any time during the screening period 6. Subject (or legally-acceptable representative) is willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder 2. Subjects with known history of congenital thrombocytopenia 3. Subjects with known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia 4. Subjects with known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant 5. Subjects with known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura 6. Subjects with positive laboratory findings of hepatitis B, hepatitis C, or human immunodeficiency virus at screening 7. Subjects with known history of infection with H. pylori 8. Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent 9. Subject has a known hypersensitivity to any recombinant E coli-derived product 10. Subjects suffering from chronic liver disease (Child-Pugh score � 7) 11. Subjects with history of any thromboembolic disease 12. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator 13. Subject is pregnant or breast feeding 14. Investigator has concerns regarding the subjects ability to comply with the protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving platelet response (i.e. ââ?°Â¥ 50000 cells/cmm)Timepoint: Weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent AEsTimepoint: Throughout the study;Presence of Anti-Romiplostim antibodyTimepoint: At predose, at visit 2, visit 14 and after 24 weeks (post study) of treatment initiation. | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed