A clinical trial to Study effects of Romiplostim in patients with chronic immune thrombocytopenia (ITP)

INTERVENTION: 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 Romiplostim (Nplate): Single‐use vials contain 250 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder CONDITION: Immune thrombocytopenic purpura PRIMARY OUTCOME: Proportion of patients achieving platelet response (i.e. â?Â¥ 50000 cells/cmm)Timepoint: Weekly SECONDARY OUTCOME: 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. 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 â?¤ 30 x 10â?¹/L at any time during the screening period 6. Subject (or legally‐acceptable representative) is willing and able to provide written informed consent