Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Romiplostim 250 mcg: Romiplostim 250 mcg lyophilised powder for solution for injection through SC injection once a week for 12 weeks. The initial dose for Romiplostim will be 1 mcg/kg b
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and Female subject in between 18 to 65 years of age. 2) Patients with chronic immune (idiopathic) thrombocytopenic purpura. per the American Society of Hematology guidelines. 3) If subject is > 60 years of age, subject had a written bone marrow biopsy report consistent with a diagnosis of ITP. 4) Subject had received at least 1 prior therapy for ITP. 5)Subject with a single platelet count less than equal to 30 x 10 raise to 9/L at any time during the screening period. 6) Subject (or legally - acceptable representative) was willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to romiplostim or any of its excipients. 2) Subject had a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder. 3) Subjects with known history of congenital thrombocytopenia, systemic lupus erythematosus, Evans syndrome, autoimmune neutropenia, antiphospholipid antibody syndrome, positive for lupus anticoagulant, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura. 4) Subjects with known history of infection with H. pylori. 5) Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent. 6) Subject has a known hypersensitivity to any recombinant E coli-derived product. 7) Subjects suffering from chronic liver disease (Child-Pugh score more than or equal to 7). 8) Subjects with history of any thromboembolic disease. 9) Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator. 10) Subject is pregnant or breast feeding. 11) Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of AEs (adverse events) and Number of adverse drug reactions (ADRs) during the study periodTimepoint: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.Timepoint: 14 weeks ;Proportion of patients achieving platelet response (achievement of a weekly platelet count more than or equal to 50 x 10 raise to 9 /L)Timepoint: 14 weeks | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Service
Outcome results
None listed